Smiths Medical has alerted customers to a potential risk of tracheostomy tube displacement or decannulation due to a flange defect in certain Bivona tracheostomy tubes.
RT’s Three Key Takeaways:
- Potential Risk Identified: Smiths Medical has identified a potential issue with certain Bivona tracheostomy tubes where a torn or broken flange could lead to tracheostomy tube displacement or decannulation, posing serious health risks.
- Customer Notification and Steps: Affected customers and distributors have been notified with specific instructions on how to check their devices and what actions to take if their tracheostomy tubes are impacted by the defect.
- FDA Involvement: The US Food and Drug Administration (FDA) has been informed of the issue, and any adverse reactions or quality problems can be reported through the FDA’s MedWatch program.
Smiths Medical has issued an urgent medical device notification to inform affected customers of a potential issue with certain Bivona tracheostomy tubes.
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 customer notification sent on May 29 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. Either event may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.
The company has notified the US Food and Drug Administration (FDA) of this action.
A list of impacted products can be found here.
Adverse reactions or quality problems experienced with this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
