BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PURPREP

    MDR report key: 12667863 · Received October 20, 2021

    Report

    Report Number
    3004932373-2021-00474
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 19, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    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.: 960120, BATCH NO.: 1166030. IT WAS REPORTED THAT ONE CASE HAD 5 DEVICES THAT WERE DAMAGED AND LEAKING. VERBATIM: SOUTHWEST MINNESOTA ORTHOPEDICS AND SPORTS MEDICINE CUSTOMER RECEIVED TWO CASES OF PURPREP. ONE OF THE CASES HAD 5 DEVICES THAT WERE DAMAGED AND LEAKING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562812 BD PURPREP POVIDONE-IODINE 8.3% W/W (0.83% AVAILABLE IODINE) KXG CAREFUSION 213, LLC 0113 1166030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other