BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ANGIOGRAPHIC KIT

    MDR report key: 12965393 · Received December 8, 2021

    Report

    Report Number
    1721504-2021-00083
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OJA
    UDI-DI
    00884450183656
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY, AND FUNCTIONAL TESTING WAS PERFORMED. THE COMPLAINT IS CONFIRMED AND THE STERILITY WAS FOUND TO BE COMPROMISED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING SEAL RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THIS WAS IDENTIFIED DURING AN INITIAL INSPECTION OF RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863683 CUSTOM ANGIOGRAPHIC KIT MERIT CUSTOM KIT OJA MERIT MEDICAL SYSTEMS INC. H2162477 00884450183656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown