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

Catalog Number	850170
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.A video of the device was however returned for analysis and the reported issue was not confirmed.The cause of the reported issue is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was reported that the trach tube exhibited a leakage between the cannula and fixation wings.When inflated, the cannula maintained the pressure of the cuff; however, when the balloon was opened, the cuff deflated.There was patient involvement, no injury was reported.

• Brand Name: BIVONA TRACHEOSTOMY CUFF 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: 23522673
• Report Number: 3012307300-2025-12325
• Device Sequence Number: 9667081
• Product Code: JOH
• UDI-Device Identifier: 15021312006780
• UDI-Public: (01)15021312006780(17)291211(10)6063444
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNKNOWN
• 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): 11/11/2025

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: 850170
• Device Lot Number: 6063444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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