BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT BLOOD GAS KIT (ABG)

    MDR report key: 494686 · Received November 7, 2003

    Report

    Report Number
    1217052-2003-00070
    Event Type
    Malfunction
    Date Received
    November 7, 2003
    Date of Event
    October 6, 2003
    Report Date
    October 7, 2003
    Manufacturer
    PORTEX, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER DRAWING BLOOD, TE FILTER-PRO WAS ATTACHED AND HEPARIN WAS BLENDED WITH BLOOD. WHEN PLACING IT ON THE TRAY, AND AFTER 20 TO 30 SECONDS, THE FILTER-PRO POPPED OFF AND SPRAYED BLOOD. NO TREATMENTS DUE TO THIS ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT BLOOD GAS KIT (ABG) TRAY, BLOOD COLLECTION GJE PORTEX, INC. NA K167422

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO