BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE DRAW ARTERIAL BLOOD GAS KIT (ABG)

    MDR report key: 613067 · Received July 19, 2004

    Report

    Report Number
    1217052-2004-00057
    Event Type
    Malfunction
    Date Received
    July 19, 2004
    Date of Event
    May 1, 2004
    Report Date
    June 21, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER EXPERIENCING PROBLEMS WITH THE PLUNGERS STICKING WHEN THEY ARE EXPELLING INITIAL FEW DROPS OF BLOOD TO CHECK FOR CLOTTING INTO A GAUZE PUD PRIOR TO EXPELLING BLOOD SAMPLE INTO ANALYZER MACHINE. PLUNGER THEN ALLEGEDLY RELEASES QUICKLY AND BLOOD GETS ONTO MACHINE AND WORK AREA. NO BLOOD EXPOSURE REPORTED.

    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 K520435

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO