Recurring concern

Failure to align product promotion with current safety information

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First reported 19 Apr 2021•Latest report 19 Apr 2021

Definition

What this concern includes

Includes failures in product marketing, promotional material or suitability claims where the promotion remains inconsistent with safety reports, amended instructions for use, field safety notices or other authoritative safety information about the product.

Not included

Excludes general product defects, packaging warnings or instructions for use that are deficient but not contradicted by promotional claims.
Excludes clinical feeding, drainage or enteral-tube management failures after the product has been supplied.
Excludes generic marketing, regulatory or information-sharing deficiencies without a direct conflict between product promotion and current safety information.
Excludes neutral product descriptions or promotion where no safety-relevant inconsistency is identified.

Reports: 2
Individual concerns: 2
Date range: 2021–2021
Stated actions: 9

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Enteral (GB) UK2

International Organization for Standardization2

NHS England2

Nursing Times2

Royal Stoke University Hospital2

Medicines and Healthcare products Regulatory Agency1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

19 Apr2021
Stoke-on-Trent and North Staffordshire
Concerns raised1
1. Failure to align product promotion with safety information about feeding and drainage suitability
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 6
1. Action
  Revise device labelling, packaging labels and Instructions For Use to remove drainage references and add ENFit limitations and safety warnings.
  Stated by GBUK Group LtdStated completed
2. Action
  Implement the revised labelling and Instructions For Use on newly manufactured stock.
  Stated by GBUK Group LtdStated planned
3. Action
  Request NHS Supply Chain to change its website description from general-use gastrostomy tubes to nasogastric feeding tubes.
  Stated by GBUK Group LtdStated completed
1. Action
  Provide refresher training to Enteral sales staff on intended use, ENFit connectors and flow-rate restrictions, with testing and ongoing training for new staff.
  Stated by GBUK Group LtdStated completed
2. Action
  Share the report with MHRA colleagues to address concerns within their remit.
  Stated by NHS EnglandStated completed
3. Action
  Review national incident reports since January 2018 and work with MHRA to determine whether further action is required.
  Stated by NHS EnglandStated in progress
Respondent positions 2
1. Position
  The sales team fully understood the tubes’ intended feeding use and their limited drainage capability, contrary to concerns that staff lacked this training.
  Stated by GBUK Group LtdDisputes the concern
1. Position
  Concerns concerning the medical device should be addressed by the Medicines and Healthcare products Regulatory Agency.
  Stated by NHS EnglandRedirects responsibility
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
Failure to align product promotion with safety information about feeding and drainage suitability
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/ ”
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
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
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 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
Review national incident reports since January 2018 and work with MHRA to determine whether further action is required.

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
2021-0114-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
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
19 Apr2021
Stoke-on-Trent and North Staffordshire
Concerns raised1
1. Continued promotion of the product as suitable for feeding and drainage despite safety information
This report raised 7 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 4
1. Action
  Continue engaging with GBUK on updating the Carefeed website instructions for use.
  Stated by Medicines and Healthcare products Regulatory AgencyStated in progress
2. 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 planned
3. Action
  Revise device labelling, packaging labels and Instructions For Use to remove drainage references and add ENFit limitations and safety warnings.
  Stated by GBUK Group LtdStated completed
1. Action
  Share the report with Medicines and Healthcare products Regulatory Agency colleagues for action on concerns within their remit.
  Stated by NHS EnglandStated completed
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
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/ ”
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
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
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

Data last updated 7 September 2026

What this concern includes

Not included

Reports over time

Concerns raised1

Failure to align product promotion with safety information about feeding and drainage suitability

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.6

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2

Concerns raised1

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

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.4

Actions described in response 6

Respondent positions 2

Actions described in response 4