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

Catalog Number	670175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the trach tube exhibited a leakage following one day of use.A replacement tube was used and the issue resolved.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
D9: 24-nov-2025.H3: two pictures were provided and one used unit was received for evaluation.The pictures showed a leak from the cuff of the set, and visual inspection of the returned device showed no damage or anomalies.Functional testing was performed and a leak was observed again at the cuff of the set.Upon closer inspection a stretch like damage was observed at the location of the leak.The complaint of leakage can be confirmed due to the damage observed.The probable cause of the damage is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23526076
• Report Number: 3012307300-2025-12356
• Device Sequence Number: 21098722
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: (01)15021312006063(17)290318(10)4451304
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• 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: Lay User/Patient
• Device Catalogue Number: 670175
• Device Lot Number: 4451304
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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