First reported 19 Apr 2021•Latest report 19 Apr 2021
Definition
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.
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
2
Distinct published reports
Individual concerns
6
A report can raise multiple concerns
Date range
2021–2021
First to latest report issue date
Stated actions
8
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
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
Company2
Executive non-departmental public body2
Healthcare site2
Standards body2
Medicines and medical devices regulator1
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.
Stoke-on-Trent and North Staffordshire
Concerns raised3
Insufficient product description of the tube bore restriction
Failure to train sales marketing staff to recognise and communicate the tube bore restriction
Wider product labelling failure to communicate the connector-related bore restriction
This report raised 4 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 An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.6
Action
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.
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.
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 completedThe respondent said that this action was complete when they made their response on 23 April 2021.
Action
Implement the revised labelling and Instructions For Use on newly manufactured stock.
Stated by GBUK Group LtdStated plannedThe respondent said that this action was planned when they made their response on 23 April 2021.
Action
Request NHS Supply Chain to change its website description from general-use gastrostomy tubes to nasogastric feeding tubes.
Stated by GBUK Group LtdStated completedThe respondent said that this action was complete when they made their response on 23 April 2021.
Action
Share the report with MHRA colleagues to address concerns within their remit.
Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 23 April 2021.
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 completedThe respondent said that this action was complete when they made their response on 23 April 2021.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
Concerns concerning the medical device should be addressed by the Medicines and Healthcare products Regulatory Agency.
Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
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 concernThe respondent disagreed with part of the concern or the basis for it.
Stoke-on-Trent and North Staffordshire
Concerns raised3
Wider product labelling problem regarding the tube's restricted bore
Failure to train sales marketing staff to recognise and communicate the tube's restricted bore
Insufficient product description of the tube's restricted bore
This report raised 5 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 An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.4
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.
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 completedThe respondent said that this action was complete when they made their response on 23 April 2021.
Action
Share the report with Medicines and Healthcare products Regulatory Agency colleagues for action on concerns within their remit.
Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 23 April 2021.
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 completedThe respondent said that this action was complete when they made their response on 23 April 2021.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.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 concernThe respondent disagreed with part of the concern or the basis for it.
Pin
Get email alerts
Request correction
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.
