BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12801310 · Received November 11, 2021

    Report

    Report Number
    3004932373-2021-00489
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 5, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE & PHOTOGRAPHS WERE RECEIVED FOR ANALYSIS SHOWING A BLACK SPECS. ONE OF THE SOURCES OF FM BLACK SPECS IS THE PRINTER OF THE PACKAGING LIDDING. ON (B)(6)2021, THE WEEKLY PREVENTIVE MAINTENANCE WAS UPDATED TO INCLUDE A THOROUGH CLEANING OF ALL ROLLERS (ADDED IDLE ROLLERS ON THE PRINTER MACHINE, MARK ANDY EQUIPMENT). NO FURTHER ACTION WILL BE TAKEN BASED ON A NEGATIVE TREND IS NOT OBSERVED AT THIS TIME. BD WILL CONTINUE TO TRACK & TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIAL NO: 930815 BATCH NO: 1193037. IT WAS REPORTED THAT THE HEALTH PROFESSIONAL FOUND BLACK RESIDUE UNDERNEATH THE STERILE PACKAGING THAT REMAINS INTACT.¿ VERBATIM: THANK YOU FOR TAKING MY CALL AND DOCUMENTING MY QUALITY COMPLAINT. AS MENTIONED, BELOW IS THE AFFECTED PART/REFERENCE NUMBER AS WELL AS THE LOT NUMBER, AND IMAGES OF THE BLACK RESIDUE UNDERNEATH THE STERILE PACKAGING THAT REMAINS INTACT. REF #(B)(4). LOT #1193037. PLEASE DO NOT HESITATE TO CONTACT ME SHALL YOU REQUIRE ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL NO: 930815, BATCH NO: 1193037. IT WAS REPORTED THAT THE HEALTH PROFESSIONAL FOUND BLACK RESIDUE UNDERNEATH THE STERILE PACKAGING THAT REMAINS INTACT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698764 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1193037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other