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

Catalog Number	FU25HN35NGE140N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bivona tracheostomy tube was in the patient and it broke in half.There was patient involvement with no harm.
Additional Manufacturer Narrative
Provided lot number was gc020590.Manufacturing date (h4) and expiry date (d4) was not available for reported lot number.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

• Brand Name: Bivona Tracheostomy Tubes
• 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: 50886584
• Report Number: 1824231-2026-00009
• Device Sequence Number: 10667690
• Product Code: JOH
• UDI-Device Identifier: 10887709167343
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: Lay User/Patient
• Device Catalogue Number: FU25HN35NGE140N
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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