An Urgent Medical Device Notification was issued for certain Bivona Tracheostomy Tubes due to a potential manufacturing defect that may cause the device to dislodge from its position in the trachea, according to an FDA alert.
A notification letter on the ICU Medical website dated May 29, 2024, notified affected customers that “Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.”
If the flange on the item is torn or broken, the tracheostomy tube may not stay in position in the trachea, according to the notification letter. The FDA notes that “This 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.”
A list of affected devices is available at the ICU Medical website and include: Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s).
