BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 9753470 · Received February 26, 2020

    Report

    Report Number
    9753470
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 10, 2020
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJH
    UDI-DI
    10888439420388
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DULL SCALPEL BLADES IN THE ORTHO TRAY-KIT, UNABLE TO EVEN CUT THROUGH IOBAN SKIN DRAPE ON INITIAL SURGICAL INCISION. THE BLADES WITHIN THE PACK ARE BARD-PARKER RIB-BACK, LOT #0200156. ALL 6 BLADES FROM THIS PACK WERE DULL. ANOTHER PACK WAS OPENED (SAME CATALOG # AND LOT#) THAT HAD AT LEAST 2 DULL BLADES IN THE PACK. SAME LOT # ON ALL BLADES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218173 CARDINAL HEALTH ORTHOPEDIC TRAY-KIT OJH CARDINAL HEALTH 200, LLC SOP56TK80H 340859 10888439420388

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA