MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Bivona Tight to Shaft Tracheostomy Tube; Tube Tracheostomy and Tube Cuff

Catalog Number	670190
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A cuff leakage was identified on the 21st day of use while the device was in use on a patient at the hospital.The issue was resolved by replacing the device with another unit.Although the patient was involved at the time of the event, no patient harm or adverse effects were reported.
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.

• Brand Name: Bivona Tight to Shaft Tracheostomy Tube
• Common Device Name: Tube Tracheostomy and Tube Cuff
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; ave calidad no. 4, parque; industrial int'l tijuana; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50838933
• Report Number: 9617604-2026-00861
• Device Sequence Number: 10060454
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 670190
• Device Lot Number: 6017516
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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