BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE -STEP FREPP 1.5 ML

    MDR report key: 1863442 · Received October 4, 2010

    Report

    Report Number
    1863442
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 4, 2010
    Manufacturer
    CAREFUSION
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHLORAPREP WAS BEING USED TO PREP SKIN BEFORE STARTING AN IV. THE PATIENT COMPLAINED, AND NURSE NOTED CUTS FROM CHLORAPREP.====================== HEALTH PROFESSIONAL'S IMPRESSION======================GLASS INSIDE DEVICE PENETRATED THROUGH MESH BARRIER, CUTTING PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHLORAPREP ONE -STEP FREPP 1.5 ML CHLORAPREP SKIN PREPARATION KXF CAREFUSION * 39699

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR