The Medicines & Healthcare products Regulatory Agency (MHRA), the UK’s regulator for the safety of medical devices, has issued an urgent field safety notice advising that Maxter Catheters, a manufacturer of disposable medical devices, has voluntarily recalled a number of its nasogastric feeding catheters.
The catheters are used during nasogastric intubation for patients who are unable to swallow and feed themselves. During this procedure, a plastic medical device (known as a nasogastric tube) is inserted through a patient’s nose and down the oesophagus so that food can be transferred directly into his or her stomach via the feeding tube.
MHRA’s urgent field safety notice explains that Maxter has received reports indicating that the plastic white cap attached to the retaining strap of the EnFit Connector found on the ENTRAL Neonates and Paediatric Nasogastric Feeding Catheters has separated from the retaining strap during manipulation and feeding. Although the reported risk of occurrence is low, the detached cap could be a serious choking hazard. A list of the affected devices can be found here.
Arran Macleod, an associate in the product liability team at Penningtons Manches, said: “The majority of patients fitted with nasogastric feeding tubes are children, many of whom will play with and manipulate the plastic cap attached to the device and, if freed, place it in their mouth. The cap should be securely fastened to the main device and it should not be possible to remove it. This presents an unnecessary and dangerous choking risk to a young patient.
“As a product liability team, we will be monitoring the situation and can advise anyone who feels that they, or a family member, have been adversely affected.”