BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 538292 · Received March 30, 2004

    Report

    Report Number
    1824231-2004-00004
    Event Type
    Malfunction
    Date Received
    March 30, 2004
    Date of Event
    March 11, 2004
    Report Date
    March 29, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BWC
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USED THE NU-TRAKE LAST NIGHT ON A PT AND THE DR REPORTED THAT IT BROKE AND HE HAD TO MANUALLY RETRIEVE A PIECE FROM THE PT'S TRACHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CRICOTHYROTOMY DEVICE BWC SMITHS MEDICAL ASD, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *