BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12615822 · Received October 12, 2021

    Report

    Report Number
    3004932373-2021-00457
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 30, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE PACKAGING WAS OPENED AND THERE WAS A SCREW IN THE PACKAGE; THEREFORE, THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. A TRAINING AWARENESS WAS PERFORMED TO ASSOCIATES AND MECHANICS ON ASSEMBLY AND PACKAGING EQUIPMENT. ALSO, AN EQUIPMENT ASSESSMENT WAS PERFORMED ON THE EQUIPMENT AND NO SCREWS WERE FOUND MISSING. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO: 930815NS BATCH NO: 1112269. IT WAS REPORTED THAT CUSTOMER FOUND FOREIGN MATTER IN PACKAGE. VERBATIM: CUSTOMER IS NOT SURE WHICH PACK THIS CHLORAPREP CAME FROM, BUT IT CAME FROM A CARDINAL PACK. IT HAS A LARGE SCREW IN IT. CREDIT THE CHLORAPREP PLEASE.

    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

    MATERIAL NO: 930815NS, BATCH NO: 1112269. IT WAS REPORTED THAT CUSTOMER FOUND FOREIGN MATTER IN PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512538 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 1112269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other