On May 29, 2024, Smiths Medical issued an urgent medical device notification to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes. The securement flange of specific lots of the Bivona® Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
According to the company, if the flange is torn or broken, the tracheostomy tube may not stay in position in the trachea, which can lead to tracheostomy displacement or decannulation. Either event may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.
As of the notification, Smiths Medical has received 35 reports of serious injury and one death associated with this issue.
All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service.
The company published a list of affected products.
