BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT BLOOD GAS KIT (ABG)

    MDR report key: 612878 · Received July 20, 2004

    Report

    Report Number
    1217052-2004-00061
    Event Type
    Malfunction
    Date Received
    July 20, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 21, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    GJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES THAT AFTER DRAWING BLOOD, THE FILTER-PRO WAS USED TO EXPEL AIR. THE SYRINGE TIP BROKE OFF SPRAYING BLOOD IN THE END-USER'S EYES. NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT BLOOD GAS KIT (ABG) TRAY, BLOOD COLLECTION GJE SMITHS MEDICAL ASD, INC. NA K524119

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO