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

Catalog Number	ZT26EN60NGZ101N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Bivona Tracheostomy Tube
• Common Device Name: Tube tracheostomy and tube cuff
• Manufacturer (Section D): ICU Medical, Inc..; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 50012669
• Report Number: 3012307300-2026-07593
• Device Sequence Number: 9572777
• Product Code: JOH
• UDI-Device Identifier: 10887709194394
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: ZT26EN60NGZ101N
• Device Lot Number: GC021813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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
• Patient Sex: Unknown