BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19710032 · Received July 10, 2024

    Report

    Report Number
    19710032
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 17, 2024
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A NEURO CRANI PACK HAD ONLY NINE '1/2 X 1' COTTONOID NEUROSURGICAL SPONGE IN THE PACK. IT WAS DISCOVERED DURING THE INITIAL COUNT. THE COTTONOID WERE COUNTED TWICE AND ONLY 9 WERE COUNTED. THEY WERE TAKEN OFF THE FIELD AND ANOTHER 1/2 X 1 COTTONOID WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472456 CARDINAL HEALTH NEUROLOGICAL TRAY OJG CARDINAL HEALTH 200, LLC SNE56NCPCZ 148619

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male