BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11947784 · Received June 7, 2021

    Report

    Report Number
    3004932373-2021-00276
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 12, 2021
    Report Date
    September 7, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE MODE WAS NOT CONFIRMED DUE TO NO SAMPLE RECEIVED. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO POST MANUFACTURING HANDLING, WHICH CAN PROVIDE ENOUGH FORCE/IMPACT TO ACTIVATE AND BREAK THE GLASS AMPOULE. DUE TO THE NATURE OF GLASS, IT IS POSSIBLE TO HAVE AN ACTIVATED APPLICATOR AND/OR BROKEN AMPOULE IF THE APPLICATOR UNDERGOES EXCESSIVE HANDLING.

    Description of Event or Problem · 0

    WHEN TRYING TO USE THE CHLORAPREP, IT WAS NOTICED THAT ITS CONTENT IS CRYSTALLIZED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    WHEN TRYING TO USE THE CHLORAPREP, IT WAS NOTICED THAT ITS CONTENT IS CRYSTALLIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845342 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0286480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other