Field Safety Notice NGPod Handheld Device and NGPod Sensors (ICN 3458)

NHSSC: 55

Alert:

• The Medicines and Healthcare products Regulatory Agency (MHRA) has issued Device Safety Information (DSI/2026/009) regarding NGPod handheld device and NGPod sensor used to test pH to aid the placement of nasogastric tubes.
• Identify, quarantine and dispose of all NGPod devices, as the manufacturer is unable to accept device returns.
• The manufacturer has ceased trading in the UK, and the products are being withdrawn from the UK market.
• See our Useful Links section to view the device safety information (DSI) from The Medicines and Healthcare products Regulatory Agency (MHRA).
• While the cessation of trading is not directly related to a current safety concern, a Field Safety Corrective Action (FSCA) was initiated earlier this year, due to two UK adverse incident reports, including one with a fatal outcome.
• In these instances, the device provided a green result, indicating contact with acidic pH, suggesting that the nasogastric tube was correctly placed when, in fact, it was found in the lung.

Products Affected:

• All devices with one of the following manufacturing codes are affected:
  • NGPOD-01
  • NGPOD- SENSOR-01 XXX (all variants).
• Seven affected products are available from NHS Supply Chain:
  • FAB85002 – Enteral Feeding Device Accessory Replacement self-test cap
  • FWM4155 – pH Reading Device For use with NGPOD pH Sensors
  • FWM4157 – Enteral Feeding Device Accessory Sensor 92cm
  • FWM85015 – Enteral Feeding Device Accessory 93.5cm refer to IFU Appendix for NG tube compatibility
  • FWM85047 – Enteral Feeding Device Accessory 114.5cm refer to IFU Appendix for NG tube compatibility
  • FWM85062 – Enteral Feeding Device Accessory 82.5cm refer to IFU Appendix for NG tube compatibility
  • FWM85131 – Enteral Feeding Device Accessory Blue Plastic Case.
• The affected products are suspended and unavailable to order and will be delisted from our catalogue.
• Please see our Useful Links section to view ICN 3420 on information about the delisted products.
• Unfortunately, there are no alternatives available for most of the affected products. Customers are advised to view the online catalogue for products they deem suitable.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products.
• See our Downloads▼ section to access the product listing and Field Safety Notice for more information on the affected products and potential alternative.

Next Steps:

• Read and follow the full instructions in the DSI and Field Safety Notice and share with all users of the affected products.
• Customers should quarantine all remaining stock and dispose of all NGPod devices.
• Complete the Customer Response Form, found page 3 of the notice, and return to ngpodqra@gmail.com.
• The MHRA advises:
  • Use alternate pH testing methods to inform placement of nasogastric tubes, in line with local and national guidelines. pH testing methods should be CE-marked and intended by the manufacturer to test human gastric aspirate
  • Review local stocks of alternative pH testing devices to ensure continuity of care.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.