MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TUBES ADULT HYPERFLEX TTS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67HA80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that there was a cuff leakage found on the day of use.The event occurred while in use with patient at the hospital.There was no medical intervention required.The event was resolved by replacing with a new one.There was a patient involvement but there was no patient harm reported.
Additional Manufacturer Narrative
One used device was returned for analysis.Functional and visual testing were performed, and the reported issue could be duplicated when the device failed leak testing per wi-10-012 rev.114.Further investigation confirmed the presence of a leak condition.However, the observed defect could not be attributed to the manufacturing process and is considered to have resulted from improper device handling outside the control of icu medical.A review of manufacturing records confirmed that all tracheostomy devices undergo leak testing during production, and sampled devices from the lot passed quality leak testing and final functional inspection prior to packaging.

• Brand Name: BIVONA TUBES ADULT HYPERFLEX TTS
• 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; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24621150
• Report Number: 3012307300-2026-02576
• Device Sequence Number: 10181425
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: (01)15021312013818(17)300522(10)6099356
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 67HA80
• Device Lot Number: 6099356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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