BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE DRAW ARTERIAL BLOOD GAS KIT (ABG)

    MDR report key: 612638 · Received July 16, 2004

    Report

    Report Number
    1217052-2004-00055
    Event Type
    Malfunction
    Date Received
    July 16, 2004
    Report Date
    June 17, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES MULTIPLE EVENTS OF PLUNGERS STICKING. NO TREATMENT DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINE DRAW ARTERIAL BLOOD GAS KIT (ABG) TRAY, BLOOD COLLECTION GJE SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO