MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	SA25EN80ZTZ261N
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 ud i#: corrected.No product has been returned and therefore a root cause cannot be determined without the sample.No lot was provided so a lot history review could not be performed.Part number sa25en80ztz261n has been manufactured twice for one-piece lots.Once in may 2025 and once in september 2025.There were no anomalies identified for either of the two lots.
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that after normal use, the foam cuff of the cannula became deformed.As a result, the patient experienced pain and a significant feeling of pressure, rendering the cannula unusable.There was patient involvement.

• 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 ; 2247062300
• MDR Report Key: 24376394
• Report Number: 3012307300-2026-01415
• Device Sequence Number: 17362236
• Product Code: JOH
• UDI-Device Identifier: 10887709159775
• UDI-Public: (01)10887709159775
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: Health Professional
• Device Catalogue Number: SA25EN80ZTZ261N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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