PFD report

Peter John Hussey · Prevention of Future Deaths report

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Issued 19 Apr 2021•Stoke-on-Trent and North Staffordshire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
8

Raised in this report

Recipients
5

Named on the report

Responses found
4

Of 5 recipients

Stated actions
10

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised8

  1. Lack of compulsory root cause analysis training for clinicians
    Part of recurring concern: Unreliable root cause analysis processes
  2. Inadequate evaluation and feedback before wholesale replacement of drainage tubes
    Part of recurring concern: Unsafe management of Ryles and nasogastric tubes
  3. Continued promotion of the product as suitable for feeding and drainage despite safety information
    Part of recurring concern: Failure to align product promotion with current safety information
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.7

  1. Action

    Continue engaging with GBUK on updating the Carefeed website instructions for use.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 23 April 2021.
  2. Action

    Contact BAPEN and NNNG to raise awareness of the nasogastric tube safety issue.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 23 April 2021.
  3. Action

    Write to UK nasogastric tube manufacturers about ENFit connector risks and request risk-assessment updates and, where applicable, corrective action, revised instructions and staff training.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 23 April 2021.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    Concerns about hospital tube evaluation, clinical response, and root-cause-analysis training are addressed by a separate NHS England and Improvement response.

    Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of compulsory root cause analysis training for clinicians

Wider context from the report

“(5) There is no compulsory training of clinicians required to undertake root cause analysis. ”

Is this part of a recurring concern?

Yes — Unreliable root cause analysis processes.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Inadequate evaluation and feedback before wholesale replacement of drainage tubes

Wider context from the report

“(3) The Hospital Trust did not fully evaluate the size 14FR tube prior to replacing all previous drainage tubes (Ryles) with the carefeed 14Fr feeding and drainage tube. Feedback was generally difficult to obtain. ”

Is this part of a recurring concern?

Yes — Unsafe management of Ryles and nasogastric tubes.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Continued promotion of the product as suitable for feeding and drainage despite safety information

Wider context from the report

“(6) Despite reports to the MHRA and issue of amended instructions for use and a field safety notice the product continues to be promoted as suitable to feeding and drainage. Please see attached link to the Nursing Times. https://www.nursingtimes.net/clinical-archive/nutrition/selection-and-management-of-commonly-used-enteral-feeding-tubes-18-02-2019/ ”

Is this part of a recurring concern?

Yes — Failure to align product promotion with current safety information.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Wider product labelling problem regarding the tube's restricted bore

Wider context from the report

“(7) This was a joint inquest into the deaths of two patients who died in quick succession as a result of the Enteral 14F nasogastric tubes being used for decompression in an emergency situation. Four similar (non-fatal) incidents followed. It was not clear to the hospital that the Enteral connector reduced the bore of the size 14Fr tube. The inquest was aware that other Hospital Trusts had also needed to change the tubes. I am concerned that the product labelling problem identified during these inquests may not be limited to the University Hospital North Midlands but is in fact a much wider problem that merits wider industry investigation and changes. ”

Is this part of a recurring concern?

Yes — Failure to communicate enteral-tube bore restrictions to end users.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to train sales marketing staff to recognise and communicate the tube's restricted bore

Wider context from the report

“(2) Enteral sales marketing staff were not trained to recognise the new restriction in the bore of the tube and were consequently unable to advise the end user of the change. ”

Is this part of a recurring concern?

Yes — Failure to communicate enteral-tube bore restrictions to end users.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Insufficient product description of the tube's restricted bore

Wider context from the report

“(1) The product description used by Enteral was insufficient to enable the end user to clearly identify that the tube marketed as a carefeed size 14FR feeding and drainage tube would not operate as a 14Fr tube due to the restricting en-fit connector. ”

Is this part of a recurring concern?

Yes — Failure to communicate enteral-tube bore restrictions to end users.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of recognition of the need to aspirate the tube

Wider context from the report

“(4) Nursing staff did not consider alternative action when the nasogastric tubes were not adequately draining. There was no general recognition of the need to aspirate the tube. ”

Is this part of a recurring concern?

Yes — Unsafe management of Ryles and nasogastric tubes.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to consider alternative action when nasogastric tubes do not adequately drain

Wider context from the report

“(4) Nursing staff did not consider alternative action when the nasogastric tubes were not adequately draining. There was no general recognition of the need to aspirate the tube. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue engaging with GBUK on updating the Carefeed website instructions for use.

Verbatim wording from the response

“We would like to address the highlighted concerns 1, 2, 6 and 7 relevant to our regulatory role. The manufacturer, GBUK, has informed us that they have updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage. The primary intended use is clearly stated as ’Feeding Tube’. We understand GBUK has recently communicated this to you. We continue to engage with GBUK on the outstanding issue regarding update to their website for the Instructions for Use (IFU) on Carefeed devices. They are currently reviewing their website and aim to complete this action within the next 2 months. The above addresses concern 1.”

Source location

2021-0115-Response-from-MHRA_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Contact BAPEN and NNNG to raise awareness of the nasogastric tube safety issue.

Verbatim wording from the response

“In addition, we have contacted the British Association for Parenteral and Enteral Nutrition (BAPEN) and the National Nurses Nutrition Group (NNNG) to raise further awareness of this issue.”

Source location

2021-0115-Response-from-MHRA_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Write to UK nasogastric tube manufacturers about ENFit connector risks and request risk-assessment updates and, where applicable, corrective action, revised instructions and staff training.

Verbatim wording from the response

“In relation to concerns 2, 6 and 7, we will continue to collaborate with NHS England and Improvement on the best way to address this issue, such as raising awareness on the Medical Devices Safety Officers’ (MDSO) network. We will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment, if not already done. We will advise that, where applicable, they should conduct a Field Safety Corrective Action (FSCA) and update their IFU, ensuring that their staff are fully trained in the changes so that they can provide advice to clinicians, where necessary. This action will be completed within 1 month.”

Source location

2021-0115-Response-from-MHRA_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Work with the Healthcare Safety Investigation Branch to test and introduce national patient safety incident investigation training.

Verbatim wording from the response

“NHS England and NHS Improvement are working with the Healthcare Safety Investigation Branch (HSIB) who are testing and introducing national patient safety incident investigation training. In addition, a patient safety incident investigation training procurement framework is also being developed to support healthcare providers and commissioners to access quality assured investigation training.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 3 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Share the report with Medicines and Healthcare products Regulatory Agency colleagues for action on concerns within their remit.

Verbatim wording from the response

“Further to the email sent on 10 June 2021 from ████████, Business Manager in my Quality Strategy Team, I am conscious that the majority of your concerns would be better placed with the Local Trust, to whom you have sent the report, and colleagues at the Medicines and Healthcare products Regulatory Agency (MHRA). The Small Bore Connector Group, which you refer to in the addresses of the report was discontinued some time ago. On that basis I have shared the report with colleagues at MHRA who I understand will address the concerns relevant to their area of work.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Pilot the Patient Safety Incident Response Framework to improve systems-based patient safety incident investigations.

Verbatim wording from the response

“Recognising that there are well identified and publicised issues with the quality of patient safety investigations in the NHS, there is ongoing work, as part of the NHS Patient Safety Strategy, to pilot a new framework for incident response: the Patient Safety Incident Response Framework (PSIRF). This framework focuses on the importance of conducting a system-based patient safety incident investigation. Much like the Serious Incident Framework, the PSIRF, and the Patient Safety Incident Investigation Standards which sit alongside it, require investigators to be appropriately trained.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 3 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Develop a procurement framework enabling healthcare providers and commissioners to access quality-assured patient safety incident investigation training.

Verbatim wording from the response

“NHS England and NHS Improvement are working with the Healthcare Safety Investigation Branch (HSIB) who are testing and introducing national patient safety incident investigation training. In addition, a patient safety incident investigation training procurement framework is also being developed to support healthcare providers and commissioners to access quality assured investigation training.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 3 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Concerns about hospital tube evaluation, clinical response, and root-cause-analysis training are addressed by a separate NHS England and Improvement response.

Verbatim wording from the response

“We understand from NHS England and Improvement that a separate response has been provided to yourself covering points 3, 4 and 5.”

Source location

2021-0115-Response-from-MHRA_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing NHS investigation frameworks require systems-based investigations by appropriately trained investigators, addressing the concern about root cause analysis training.

Verbatim wording from the response

“In relation to concern 5, around Root Cause Analysis training, it is important to note that all NHS trusts are required to comply with the Serious Incident Framework (2015) when conducting patient safety incident investigations into incidents such as the tragic events described. The Framework states that;”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 23 April 2021

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. 1

    Continue collaborating with NHS England and Improvement on measures to address nasogastric tube aspiration and decompression risks.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 23 April 2021.
  2. 2

    Review National Reporting and Learning System records for relevant incidents reported since January 2018.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 23 April 2021.
  3. 3

    Work with the Medicines and Healthcare products Regulatory Agency to determine whether further action is required after completing the incident review.

    Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 23 April 2021.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    Most concerns should be addressed by the Local Trust and MHRA, with MHRA handling matters within its area of work.

    Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue collaborating with NHS England and Improvement on measures to address nasogastric tube aspiration and decompression risks.

Verbatim wording from the response

“In relation to concerns 2, 6 and 7, we will continue to collaborate with NHS England and Improvement on the best way to address this issue, such as raising awareness on the Medical Devices Safety Officers’ (MDSO) network. We will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment, if not already done. We will advise that, where applicable, they should conduct a Field Safety Corrective Action (FSCA) and update their IFU, ensuring that their staff are fully trained in the changes so that they can provide advice to clinicians, where necessary. This action will be completed within 1 month.”

Source location

2021-0115-Response-from-MHRA_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review National Reporting and Learning System records for relevant incidents reported since January 2018.

Verbatim wording from the response

“In terms of wider patient safety, NHSE/I’s Patient Safety Team have discussed this issue and are currently undertaking a review of the National Reporting and Learning System (NRLS) to see if they can identify any reported incidents since January 2018; when GBUK issued a Field Safety Notice in respect of this issue. Pending the outcome of this review, Patient Safety colleagues will work with MHRA to determine if any further action is required.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Work with the Medicines and Healthcare products Regulatory Agency to determine whether further action is required after completing the incident review.

Verbatim wording from the response

“In terms of wider patient safety, NHSE/I’s Patient Safety Team have discussed this issue and are currently undertaking a review of the National Reporting and Learning System (NRLS) to see if they can identify any reported incidents since January 2018; when GBUK issued a Field Safety Notice in respect of this issue. Pending the outcome of this review, Patient Safety colleagues will work with MHRA to determine if any further action is required.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 23 April 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Most concerns should be addressed by the Local Trust and MHRA, with MHRA handling matters within its area of work.

Verbatim wording from the response

“Further to the email sent on 10 June 2021 from ████████, Business Manager in my Quality Strategy Team, I am conscious that the majority of your concerns would be better placed with the Local Trust, to whom you have sent the report, and colleagues at the Medicines and Healthcare products Regulatory Agency (MHRA). The Small Bore Connector Group, which you refer to in the addresses of the report was discontinued some time ago. On that basis I have shared the report with colleagues at MHRA who I understand will address the concerns relevant to their area of work.”

Source location

2021-0115-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 23 April 2021

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
4/5

Data last updated 7 September 2026