BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINOR GENERAL PACK

    MDR report key: 19018627 · Received April 2, 2024

    Report

    Report Number
    19018627
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 10, 2024
    Report Date
    March 11, 2024
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN DOING INITIAL COUNTS PRIOR TO CASE START IT WAS FOUND THAT THERE WERE 9 RAYTECS IN THE MINOR GENERAL PACK INSTEAD OF THE EXPECTED 10. THE ITEMS WERE REMOVED AND A NEW PACKAGE OF RAYTECS WERE OPENED AND USED INSTEAD. MINOR GENERAL PACK IS ITEM # DYNJ44494B, LOT # 23KDA849. EXPIRATION DATE IS 2028-06-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362575 MINOR GENERAL PACK GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNJ44494B 23KDA849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown