BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP

    MDR report key: 1662912 · Received April 9, 2010

    Report

    Report Number
    1662912
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    MEDLINE
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS PREPPING SKIN USING A CAREFUSION CHLORAPREP AND WHILE SQUEEZING THE TUBE THE GLASS BROKE THROUGH THE PLASTIC LINING-CUTTING HER.THERE HAVE BEEN RECENT PROBLEMS. ALSO, THE PRODUCT WAS SOMETIMES DRY WHEN PACKET WAS OPEN.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PRODUCT WAS USED IN THE APPROPRIATE MANNER, BUT THE GLASS BROKE THROUGH THE OUTER PLASTIC.====================== MANUFACTURER RESPONSE FOR ANTISEPTIC, CHLORAPREP======================WILL PERFORM QA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHLORAPREP SKIN ANTISEPTIC KXF MEDLINE NA 34892

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR