BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 12273548 · Received August 4, 2021

    Report

    Report Number
    12273548
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 26, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OVN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CARDINAL HEALTH 200, LLC ER LACERATION TRAY HAS BEEN FOUND REPEATEDLY HAVING POOR QUALITY NEEDLE HOLDERS. THE INITIAL ROLL OUT OF THESE ER LACERATION TRAYS HAD NEEDLE HOLDERS THAT DID NOT SECURELY HOLD THE NEEDLE. THE KITS WERE RECALLED, REMOVED, AND REPLACED, BUT THE ISSUE IS STILL OCCURRING. THIS IS THE THIRD KIT THIS WEEK WITH POOR QUALITY NEEDLE HOLDERS. DIFFERENT LOTS HAVE BEEN USED. TODAY'S ISSUE IS WITH LOT #598878. OTHER RESOURCES HAD TO BE UTILIZED LEADING TO DELAY IN CARE/TREATMENT AS A NEW RESOURCE WAS OBTAINED BY THE HEALTH CARE PROVIDERS. IN ADDITION, OBTAINING THE RESOURCE ALSO REQUIRED ADDITIONAL STAFF TO BE PULLED FROM OTHER TASKS, IMPACTING OTHER PATIENTS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172803 CARDINAL HEALTH SUTURE KIT OVN CARDINAL HEALTH 200, LLC ACS-S-LAC4 598878

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA