Summary: Smiths Medical has issued an urgent notification for certain Bivona Tracheostomy Tubes due to a defect that may cause improper ventilation. Customers are advised to check if their products are affected and follow instructions provided by the company.
Key Takeaways:
- The manufacturing defect may cause tearing of the securement flange, potentially leading to tracheostomy displacement and serious health risks.
- Customers should consult the notification letter from Smiths Medical and report any adverse events to the FDA.
Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona Tracheostomy Tubes that can result in improper ventilation.
Issue with Securement Flange
The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
The customer notification indicated that if the flange on the item is torn or broken, the tracheostomy tube may not stay in position in the trachea. This can lead to tracheostomy displacement or decannulation, which may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.
Customer Guidance and Steps to Take
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 an affected product in service. A copy of that letter as well as a list of affected products can be accessed on ICU Medical’s website.
The U.S. Food and Drug Administration (FDA) has been notified of this action. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
