Recurring concern

Failure to communicate enteral-tube bore restrictions to end users

First to latest report 19 Apr 2021 — 19 Apr 2021

Reports that mention this concern
2
Times this concern has been raised
6
Stated actions linked to this concern
8

What this concern includes

Includes failures in the dedicated process for ensuring enteral-tube sales and marketing staff recognise changed bore restrictions and communicate them accurately to end users, including inadequate staff preparation where it directly prevents that communication.

What is not included
  • Excludes generic sales, marketing or staff-training deficiencies not specifically connected to communicating enteral-tube bore restrictions.
  • Excludes unrelated enteral-tube design, manufacturing, placement, feeding or clinical-management failures where communication of the bore restriction is not the unsafe condition.
  • Excludes general product warnings or promotion failures unless they specifically concern communicating an enteral-tube bore restriction to end users.

Reports and published responses 2 reports

See individual reports that have raised this concern, and the actions taken in response

  1. Stoke-on-Trent and North Staffordshire

    AI-generated summary

    Stephen James Oakes · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Stephen James Oakes, aged 59, died in hospital on 23 December 2017 after a carefeed 14F nasogastric tube inadequately drained stomach contents, allowing vomit to pass the tube and leading to aspiration pneumonia in the context of metastatic bronchial carcinoma and small bowel obstruction. The principal concerns included inadequate product description and staff training, insufficient hospital evaluation of the tube, failure to recognise inadequate drainage or consider alternatives, and possible wider product-labelling problems.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Insufficient product description of the tube bore restriction

    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. ”

    Source location

    Stephen James Oakes · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Failure to train sales marketing staff to recognise and communicate the tube bore restriction

    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. ”

    Source location

    Stephen James Oakes · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Wider product labelling failure to communicate the connector-related bore restriction

    Wider context from the report

    “(7) This was a joint inquest into the death of two patients who died in quick succession as a result of the Enteral 14F nasogastric tube 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 need 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. ”

    Source location

    Stephen James Oakes · Prevention of Future Deaths report
    Page 2 · concerns

    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

    Write to UK nasogastric-tube manufacturers about ENFit connector risks and request risk-assessment updates, with advice on applicable corrective actions, 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

    2021-0114-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

    Revise device labelling, packaging labels and Instructions For Use to remove drainage references and add ENFit limitations and safety warnings.

    Verbatim wording from the response

    “Firstly, addressing concerns raised relating to the device description and the restriction posed by the ENFit connector when used for drainage on some larger Fr size tubes. We have now revised our device labelling and the Instructions For Use (IFU), with all references to drainage now completely removed from our device labelling descriptions.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · 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

    Implement the revised labelling and Instructions For Use on newly manufactured stock.

    Verbatim wording from the response

    “The term drainage has been removed from the “Intended Use” section of the IFU and packaging labels. In the revised IFU we clearly identify to the user that the intended use of the product is a feeding tube. The additional warnings & precautions in the revised IFU further explain very clearly the limitations of the tube if the user opts to use the tube for the dual purposes of feeding and drainage. This will be implemented as new stock of these devices are manufactured.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · 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

    Request NHS Supply Chain to change its website description from general-use gastrostomy tubes to nasogastric feeding tubes.

    Verbatim wording from the response

    “We have also contacted NHS supply chain to request the device description be changed on their website from “Gastrostomy tubes for general use” to “Nasogastric Feeding Tube”, which we hope will be implemented soon.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · 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 MHRA colleagues to address 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 addressees 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

    2021-0114-Response-from-NHS-England-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

    Provide refresher training to Enteral sales staff on intended use, ENFit connectors and flow-rate restrictions, with testing and ongoing training for new staff.

    Verbatim wording from the response

    “Regarding concerns that our Enteral sales staff were not trained to recognise the restriction posed by the ENFit connector, in order to advise end users. I reiterate the point made in my previous correspondence to you (19th April 2021), that all members of the Enteral sales team fully understand that our Nasogastric Feeding tubes are not a replacement for a Ryles tube, with its primary purpose being that of feeding and its secondary purpose being limited forms of drainage.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · 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 concerning the medical device should be addressed by the Medicines and Healthcare products Regulatory Agency.

    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 addressees 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

    2021-0114-Response-from-NHS-England-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

    The sales team fully understood the tubes’ intended feeding use and their limited drainage capability, contrary to concerns that staff lacked this training.

    Verbatim wording from the response

    “Regarding concerns that our Enteral sales staff were not trained to recognise the restriction posed by the ENFit connector, in order to advise end users. I reiterate the point made in my previous correspondence to you (19th April 2021), that all members of the Enteral sales team fully understand that our Nasogastric Feeding tubes are not a replacement for a Ryles tube, with its primary purpose being that of feeding and its secondary purpose being limited forms of drainage.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · response
    Published 23 April 2021

    Open published response

  2. Stoke-on-Trent and North Staffordshire

    AI-generated summary

    Peter John Hussey · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Peter John Hussey died after post-surgical complications following reversal of an ileostomy. A carefeed 14F nasogastric tube inadequately drained his stomach, allowing vomiting and contributing to aspiration pneumonia. Concerns included insufficient product description and staff training, inadequate evaluation of the tube, and failure to recognise poor drainage and consider alternative treatment or escalation.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

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

    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. ”

    Source location

    Peter John Hussey · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    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. ”

    Source location

    Peter John Hussey · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    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. ”

    Source location

    Peter John Hussey · Prevention of Future Deaths report
    Page 2 · concerns

    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

    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

    Revise device labelling, packaging labels and Instructions For Use to remove drainage references and add ENFit limitations and safety warnings.

    Verbatim wording from the response

    “Firstly, addressing concerns raised relating to the device description and the restriction posed by the ENFit connector when used for drainage on some larger Fr size tubes. We have now revised our device labelling and the Instructions For Use (IFU), with all references to drainage now completely removed from our device labelling descriptions.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · 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

    Provide refresher training to Enteral sales staff on intended use, ENFit connectors and flow-rate restrictions, with testing and ongoing training for new staff.

    Verbatim wording from the response

    “Regarding concerns that our Enteral sales staff were not trained to recognise the restriction posed by the ENFit connector, in order to advise end users. I reiterate the point made in my previous correspondence to you (19th April 2021), that all members of the Enteral sales team fully understand that our Nasogastric Feeding tubes are not a replacement for a Ryles tube, with its primary purpose being that of feeding and its secondary purpose being limited forms of drainage.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · 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

    The sales team fully understood the tubes’ intended feeding use and their limited drainage capability, contrary to concerns that staff lacked this training.

    Verbatim wording from the response

    “Regarding concerns that our Enteral sales staff were not trained to recognise the restriction posed by the ENFit connector, in order to advise end users. I reiterate the point made in my previous correspondence to you (19th April 2021), that all members of the Enteral sales team fully understand that our Nasogastric Feeding tubes are not a replacement for a Ryles tube, with its primary purpose being that of feeding and its secondary purpose being limited forms of drainage.”

    Source location

    Response-from-GBUK-Group-Ltd_Published
    Page 1 · response
    Published 23 April 2021

    Open published response

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026