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

Catalog Number	67P045
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that after inflating the balloon, the clinician returned to the patient and found that the tracheostomy tube balloon had detached and was missing.There was patient involvement, and no harm was reported.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• 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 industrial int; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25739320
• Report Number: 3012307300-2026-07145
• Device Sequence Number: 10458941
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: (01)15021312006285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: 67P045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 18 YR
• Patient Sex: Unknown