BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOMIZED HYPERFLEX TRACHEOSTOMY TUBES

    MDR report key: 1972638 · Received January 19, 2011

    Report

    Report Number
    2183502-2010-00661
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 13, 2011
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND REPLACEMENT. IT IS ALLEGED THAT AFTER AN UNK AMOUNT OF TIME IN SITU, THE TRACHEOSTOMY TUBE TORN NEAR THE FLANGE REQUIRING REPLACEMENT. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOMIZED HYPERFLEX TRACHEOSTOMY TUBES JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1