BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE

    MDR report key: 23958630 · Received January 5, 2026

    Report

    Report Number
    3012307300-2026-00041
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    August 12, 2025
    Report Date
    January 5, 2026
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006032
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 1824231-2025-00024-00. THE DATE OF THAT SUBMISSION WAS 09-FEB-2025. H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CUFF FAILED TO INFLATE AND A LEAK WAS OBSERVED IMMEDIATELY AFTER FILLING. THE COMPLAINT OF LEAKAGE CANNOT BE CONFIRMED NOR REPLICATED. THE PROBABLE CAUSE IS UNKNOWN. VISUAL INSPECTION THERE WERE NO DAMAGES OR ANOMALIES OBSERVED. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIRST TRACHEOSTOMY TUBE WAS PLACED AND SHOWED LEAKAGE AFTER 17 DAYS OF USE WITH A PATIENT. THE INCIDENT OCCURRED AT THE PATIENT¿S HOME AND WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THE ISSUE WAS RESOLVED BY REPLACING THE TUBE WITH A NEW ONE. A SAMPLE PHOTO PROVIDED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18136 BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 4255456 15021312006032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown