BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP FREPP APPLICATOR

    MDR report key: 1209024 · Received October 13, 2008

    Report

    Report Number
    1209024
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 13, 2008
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHLEBOTOMIST USED A CHLORAPREP TO PREPARE PATIENT'S SKIN FOR A BLOOD DRAW. THE PHLEB SWIPED THE SPONGE OVER THE SKIN SEVERAL TIMES CAUSING THE PATIENT TO CRY OUT WITH PAIN. THE PHLEB IMMEDIATELY PULLED THE SPONGE AWAY AND NOTED FRESH BLOOD ON THE SPONGE. THE PATIENT WAS LEFT WITH MULTIPLE DEEP SCRATCHES TO THE AREA PREPPED BY THE SPONGE. SUBSEQUENTLY A SHARD OF GLASS WAS FOUND PROTRUDING FROM THE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHLORAPREP ONE-STEP FREPP APPLICATOR TREATED SPONGE APPLICATOR KXF CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES * 23632

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR