BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA ADULT TTS TRACHEOSTOMY TUBE

    MDR report key: 3932426 · Received April 2, 2014

    Report

    Report Number
    2183502-2014-00176
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    February 24, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SMITHS MEDICAL ASD
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED. METHOD CODE, OTHER: A SAMPLE DEVICE WAS RETURNED AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED ON BEHALF OF USER FACILITY THAT THE TRACHEOSTOMY TUBE WAS FOUND TO BE DEFLATING AT THE CUFF AFTER 14 DAYS IN SITU. REPLACEMENT OF THE TUBE WAS REQUIRED. NO ADVERSE EFFECTS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199998 BIVONA ADULT TTS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK