BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAND NAME LINE DRAW ARTERIAL BLOOD GAS KIT (ABG)

    MDR report key: 602675 · Received July 2, 2004

    Report

    Report Number
    1217052-2004-00052
    Event Type
    Malfunction
    Date Received
    July 2, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 11, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES MULTIPLE EVENTS OF THE PLUNGERS STICKING WHEN TRYING TO INTRODUCE A SAMPLE INTO THEIR ISTAT CARTRIDGE. HOSP PULLS A 0.5 TO 1.0ML OF BLOOD FOR SAMPLES. THEY DO NOT ICE THE SAMPLE. UPON THE BLOOD DRAW THE SAMPLE IS IMMEDIATELY PLACED INTO THE CARTRIDGE. NO TREATMENT DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAND NAME LINE DRAW ARTERIAL BLOOD GAS KIT (ABG) TRAY, BLOOD COLLECTION GJE SMITHS MEDICAL ASD, INC. NA K520432

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO