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

Catalog Number	670180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach tube exhibited a leakage.Upon removal, the leakage was found at the inflation line.Another trach tube was used and the issue resolved.There was patient involvement, unknown injury was reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 1824231-2025-00028-00.The date of that submission was 11-dec-2025.H6: codes were updated.One device was returned for investigation.It was reported that a slow leak in the airway at the location where damage was identified during the visual inspection.The defect could be confirmed.All tracheostomy devices are leak tested twice prior to being sent to the customer, therefore this device did not leak during final functional testing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TUBES ADULT TIGHT TO SHAFT 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24389727
• Report Number: 3012307300-2026-01487
• Device Sequence Number: 15998773
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: (01)15021312006070(17)290604(10)4462495
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083641
• 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
• Report Date (Section B): 02/19/2026

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: 670180
• Device Lot Number: 4462495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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