ICU Medical’s Smiths Medical issued an urgent field safety notice to warn of a potential defect with some of its Bivona tracheostomy products.
Posted out of Germany, the warning applies to a number of Bivona neonatal/pediatric and adult tracheostomy tubes. That includes the Aire-Cuf, TTS, Uncuffed and Mid-Range Bivona tubes for neonatal/pediatric uses. For adults, the notice covers the Aire-Cuf, TTS, Cuffless FlexTend and TTS FlexTend tubes.
Smiths Medical said it identified that the securement flange of certain tubes may tear due to a manufacturing defect. If the flange tears or breaks, the tube may not remain in position within the trachea. This can lead to tracheostomy displacement or decannulation. Either event may result in an inability to properly ventilate or protect the airway. Either can contribute to a “catastrophic adverse event.”
According to the safety notice out of Germany, Smiths Medical received 35 reports of serious injury and one reported death associated with the issue.
Customers should discard all affected products after conducting an investigation of their inventory. If discarding is not an immediate option, affected devices should be quarantined until they can be disposed of. The company plans to provide replacement products or credit to affected customers upon receipt of a completed response form that certifies product destruction.
