BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT ARTERIAL BLOOD SAMPLING KIT

    MDR report key: 444497 · Received February 21, 2003

    Report

    Report Number
    1217052-2003-00019
    Event Type
    Malfunction
    Date Received
    February 21, 2003
    Date of Event
    November 22, 2002
    Report Date
    January 22, 2003
    Manufacturer
    PORTEX, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY HAD ONE EVENT OF BLOOD PAST THE PLUNGER. THERE WAS BLOOD EXPOSURE BUT NOT TO MUCOUS MEMBRANES. THE CLINICIAN DID NOT REQUIRE ANY TREATMENT BEYOND CLEANING OF THE EXPOSED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT ARTERIAL BLOOD SAMPLING KIT TRAY, BLOOD COLLECTION GJE PORTEX, INC. NA K143082

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR