BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMS

    MDR report key: 226795 · Received June 11, 1999

    Report

    Report Number
    226795
    Event Type
    Injury
    Date Received
    June 11, 1999
    Date of Event
    May 12, 1999
    Report Date
    May 14, 1999
    Manufacturer
    SIMS MIDICAL SYSTEMS
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PUSHING AIR OUT OF SYRINGE WITH FILTER PRO IN PLACE, AIR AND BLOOD ESCAPED SYRINGE. THE FILTER PRO WAS DISLODGED, CAUSING APPROX 3 CC'S OF BLOOD TO SPLATTER INTO ENVIRONMENT AND ONTO THIS PERSON'S SKIN AND MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS PRO-VENT ARTERIAL BLOOD GAS KIT GJE SIMS MIDICAL SYSTEMS UNK 811561

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention