MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TRACHEOSTOMY TUBE, PEDIATRIC AND NEONATAL HYPERFLEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	65P055
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction

• Brand Name: BIVONA TRACHEOSTOMY TUBE, PEDIATRIC AND NEONATAL HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; parque ind internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25751744
• Report Number: 3012307300-2026-07215
• Device Sequence Number: 21353896
• Product Code: JOH
• UDI-Device Identifier: 15021312006001
• UDI-Public: (01)15021312006001(17)300825(10)6137766
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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: 65P055
• Device Lot Number: 6137766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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