BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE

    MDR report key: 21573145 · Received March 11, 2025

    Report

    Report Number
    3012307300-2025-02678
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 2, 2026
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312013818
    PMA / PMN Number
    K081440
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. 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.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE RETURN PRODUCT SHOWED THE PIN WAS REMOVED FROM THE LOCKING STRAP. THERE ARE SIGNS THE PIN WAS SEATED AT ONE TIME. THE PIN WAS RESEATED BY FOLLOWING WI-09-0310-24 SECTION 8.11. THE PIN WENT IN AND LOCKED THE LOCKING STRAP AND TRIED TO FORCIBLY PULL THE PIN OUT BUT COULD NOT REMOVE THE PIN. THE GARY SITE NO LONGER MANUFACTURES THE ADULT ADJUSTABLE PRODUCT, THE PROCESS HAS MOVED TO TIJUANA, MEXICO AND REACHED OUT TO TIJUANA TO GET INFORMED OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SECOND DAY OF THE PATIENT'S TREATMENT, THE LOCKING PIN CAME LOOSE FROM THE TUBE. A NEW TRACHEOSTOMY TUBE WAS USED TO FIX THE ISSUE. THE INCIDENT OCCURRED WHILE THE PATIENT WAS BEING TREATED. THE EVENT OCCURRED IN THE HOSPITAL AND WAS OPERATED BY HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221626 BIVONA TTS ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 4267588 15021312013818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention