BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 8578792 · Received May 3, 2019

    Report

    Report Number
    1721504-2019-00030
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OJA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR 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
    373580 MERIT CUSTOM KIT CUSTOM KIT OJA MERIT MEDICAL SYSTEMS INC. H1434618

    Patients

    Seq Age Sex Outcome Treatment
    1