BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 18290671 · Received December 8, 2023

    Report

    Report Number
    18290671
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 2, 2023
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: ONE ORTHO TRAUMA PACK WITH LOT NUMBER 120601, MANUFACTURER DATE [REDACTED DATE], AND EXPIRATION [REDACTED DATE], WAS FOUND TO HAVE ITS TOWELS CONTAMINATED WITH RED AND YELLOW FLECKS. NO OTHER ITEMS IN THE PACK APPEARED TO HAVE ANY RED OR YELLOW FLECKS ON THEM, NOR WAS THERE ANYTHING IN THE PACK THAT MATCHED THOSE COLORS. THE FLECKS WERE UNABLE TO BE REMOVED FROM THE TOWELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366566 CARDINAL HEALTH ORTHOPEDIC TRAY OJH CARDINAL HEALTH 200, LLC SOP13OTEMY 120601

    Patients

    Seq Age Sex Outcome Treatment
    1 8030 DA Female