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

Catalog Number	ST25DN95ZSZ185N
Medical Device Problem Codes	Deflation Problem (1149); Connection Problem (2900); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector/adapter of the custom-made tracheostomy tube slipped into the cuff, making it impossible to connect with a disposable syringe and also it cannot be easily deflated during an emergency trach change, only with great difficulty by pushing the adapter back into its original position.There was patient involvement but no harm.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
One used unit was received for evaluation.Visual inspection of the returned sample identified that the inflation valve was positioned deep into the pilot balloon.Using magnification to inspect the opening of the pilot balloon, no tears or cuts were observed that would prevent the inflation valve from seating properly into the pilot balloon.No manufacturing defects were identified with the pilot balloon.Functional testing was performed and the unit tested normally.The investigation determined that device was manufactured to specification.Rotational and horizontal forces likely were applied to the inflation valve, which caused it to be forced into the pilot balloon.

• Brand Name: BIVONA CUSTOMIZED 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 ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24521151
• Report Number: 3012307300-2026-02091
• Device Sequence Number: 15892535
• Product Code: JOH
• UDI-Device Identifier: 10887709155739
• UDI-Public: (01)10887709155739(17)300425(10)GC003816
• 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: ST25DN95ZSZ185N
• Device Lot Number: GC003816
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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