BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11499813 · Received March 16, 2021

    Report

    Report Number
    3004932373-2021-00129
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 17, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: 930815 BATCH NO.: 0327867 IT WAS REPORTED THAT THE TOP OF THE APPLICATOR CAME OFF AND THE GLASS FELL OUT ONTO THE FLOOR. PER COMPLAINT FORM: GOOD MORNING, I'VE HAD TWO CHLORAPREP 26ML STICKS BUST THIS WEEK. THE NURSE POPPED THE STICK AND THE TOP FELL OFF AND ALL OF THE LITTLE GLASS PARTICLES (IS IT GLASS?) FELL OUT ALL OVER THE FLOOR. I WAS ABLE TO SAVE THE PACKAGE TODAY AND THE REF # 930815, LOT# 0327867. HAVE YOU HAD ANY OTHERS IN THIS LOT DO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393512 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0327867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other