MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Bivona Tight to Shaft Tracheostomy Tube; Tube tracheostomy and tube cuff

Catalog Number	670160
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Anxiety (2328); Low Oxygen Saturation (2477)
Date of Event	12/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ventilator-dependent patient experienced acute respiratory compromise due to repeated cuff failures of bivona tight-to-shaft tracheostomy tubes.The cuffs repeatedly failed to maintain inflation, causing major air leaks, low tidal volumes, increased ventilator pressures, oxygen desaturation, agitation, and respiratory distress.Emergency tube changes and other interventions were required.Similar cuff failures occurred with multiple tubes of the same brand and size, suggesting a possible device-related issue.The problem resolved after replacing the tube with a different size, restoring effective ventilation and the patient¿s baseline condition.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2026-00191-00.The date of that submission was 10-aug-2026.One used device was returned for investigation.Device history review was performed, and no nonconformities were identified that may have contributed to the reported complaint.The visual inspection and functional testing were performed and found that the cuff failed to inflate, and a leak was observed immediately after filling.The customer complaint was confirmed.The cause of the reported issue was unknown.

• Brand Name: Bivona Tight to Shaft Tracheostomy Tube
• Common Device Name: Tube tracheostomy and tube cuff
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; avenida calidad no.4, parque; industrial internacional; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 50279857
• Report Number: 3012307300-2026-08122
• Device Sequence Number: 9752766
• Product Code: JOH
• UDI-Device Identifier: 15021312006032
• UDI-Public: (01)15021312006032(17)280730(10)4421210
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CA
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 670160
• Device Lot Number: 4421210
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown