BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMS

    MDR report key: 226806 · Received June 11, 1999

    Report

    Report Number
    226806
    Event Type
    Injury
    Date Received
    June 11, 1999
    Date of Event
    May 1, 1999
    Report Date
    May 14, 1999
    Manufacturer
    SIMS MEDICAL 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 3CC'S OF BLOOD TO SPLATTER INTO ENVIRONMENT AND ONTO THIS PERSON'S SKIN AND MUCOUS MEMBRANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS PRO-VENT ARTERIAL BLOOD GAS KIT GJE SIMS MEDICAL SYSTEMS UNK 902107

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention