BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM BIVONA HYPERFLEX TRACHEOSTOMY TUBES

    MDR report key: 4912789 · Received July 14, 2015

    Report

    Report Number
    2183502-2015-00510
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 14, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND INVESTIGATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THE LISTED DEVICE WAS FOUND SLOWLY LEAKING FROM THE DEVICE CUFF WHILE IN USE. THE REPORTER DOES NOT KNOW HOW LONG THE DEVICE WAS IN USE OR IF THE DEVICE HAD BEEN REPROCESSED. NO ADVERSE HEALTH EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455791 CUSTOM BIVONA HYPERFLEX TRACHEOSTOMY TUBES TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA CS027898

    Patients

    Seq Age Sex Outcome Treatment
    1