MAUDE Adverse Event Report: ICU Medical, Inc. Bivona Tracheostomy Tube; Tube tracheostomy and tube cuff

Catalog Number	ZZ26DN35NGF198N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Bivona Tracheostomy Tube
• Common Device Name: Tube tracheostomy and tube cuff
• Manufacturer (Section D): ICU Medical, Inc.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50596628
• Report Number: 1824231-2026-00008
• Device Sequence Number: 10225967
• Product Code: JOH
• UDI-Device Identifier: 10887709192154
• UDI-Public: (01)10887709192154
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZZ26DN35NGF198N
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown