Concerns raised 7 Failure to align product promotion with safety information about feeding and drainage suitability View source Insufficient product description of the tube bore restriction View source Failure to fully evaluate the size 14FR tube before replacing previous drainage tubes View source Lack of compulsory root cause analysis training for clinicians View source Failure to train sales marketing staff to recognise and communicate the tube bore restriction View source Failure to respond appropriately when NG tubes are not adequately draining View source Wider product labelling failure to communicate the connector-related bore restriction View source See 4 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
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. The report was sent to International Organization for Standardization; that does not assign responsibility.
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/
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does not assign responsibility.
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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does not assign responsibility.
PFD Monitor interpretation Failure to fully evaluate the size 14FR tube before replacing previous 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 14F feeding and drainage tube . Feedback was generally difficult to obtain .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does not assign responsibility.
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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does not assign responsibility.
PFD Monitor interpretation Failure to respond appropriately when NG tubes are not adequately draining
Wider context from the report “(4) Nursing staff did not consider alternative action when the NG tubes were not adequately draining . There was no general recognition of the need to aspirate the tube .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does not assign responsibility.
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.
” Open source report
Concerns raised 8 Lack of compulsory root cause analysis training for clinicians View source Inadequate evaluation and feedback before wholesale replacement of drainage tubes View source Continued promotion of the product as suitable for feeding and drainage despite safety information View source Wider product labelling problem regarding the tube's restricted bore View source Failure to train sales marketing staff to recognise and communicate the tube's restricted bore View source Insufficient product description of the tube's restricted bore View source Lack of recognition of the need to aspirate the tube View source Failure to consider alternative action when nasogastric tubes do not adequately drain View source See 5 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
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. The report was sent to International Organization for Standardization; that does 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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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/
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to International Organization for Standardization; that does 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.
” Open source report
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations