Errors with depth markings on Vygon devices could lead to incorrect placement
Medical device regulators have issued an alert amid fears nasogastric feeding tubes could be incorrectly placed due to an error with depth markings.
The Medical Device Alert from the Medicines and Healthcare products Regulatory Agency (MHRA) affects Ryles feeding tubes with weighted tips manufactured by Vygon. The warning applies to Size 12FG 125cm, product code: 392.12, lot number: 160412FG and Size 14FG 125cm, product code: 392.14, lot number: 100512FF.
The affected product codes on the manufacturer’s website and device labels are specified as ‘392.12’ and ‘392.14‘. The same products are referred to as ‘0392.12’ and ‘0392.14’ respectively in the manufacturer’s Field Safety Notices.
The alert warns of a risk of incorrect placement of the feeding tube due to incorrectly applied depth markings and, despite, issuing two safety notices in January, Vygon said it has not received sufficient confirmation from users that they have received and acted on this information.
Healthcare organisations are being advised to identify and quarantine any affected devices and to ensure all users are aware of the warnings. If patients already have affected tubes in situ, healthcare workers should confirm correct placement before further use.
Click here to see the warning in full.