UK MHRA has issued a Medical Device Alert relating to Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes manufactured by Smiths Medical. According to the alert, which was issued on Thursday 19th January, incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect. This may cause the tube to dislodge, requiring it to be changed.
The manufacturer has initiated a recall of affected tubes. Despite issuing a Field Safety Notice in November it has not had confirmation from all users that they have received and acted on this information.
The action affects all staff responsible for the care of neonatal and paediatric patients with tracheostomy tubes as well as personnel involved in the purchase, supply and distribution of these devices.
The alert can be found here and includes guidance for patients who may already have one of the identified products fitted.