MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Bivona Tubes Adult Aire-Cuf; Tube Tracheostomy and Tube Cuff

Catalog Number	750180
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Bivona Tubes Adult Aire-Cuf
• 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 international; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north,; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 50035244
• Report Number: 3012307300-2026-07741
• Device Sequence Number: 9908640
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: (01)15021312006421(17)300707(10)6130527
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: Other
• Device Catalogue Number: 750180
• Device Lot Number: 6130527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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: Female
• Patient Weight: 123 LB