BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 11784267 · Received May 6, 2021

    Report

    Report Number
    1721504-2021-00029
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OEQ
    UDI-DI
    00884450236642
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE UNIT WAS RETURNED FOR INVESTIGATION. THE RETURNED UNIT WAS FILLED WITH FLUID AND PRESSURIZED, THE CONNECTION WAS CONFIRMED TO BE LEAKING. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS, OPERATOR ERROR. A DHR REVIEW WAS PERFORMED AND NO EXCEPTION DOCUMENTS HAVE BEEN NOTED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT THE SALINE CONNECTION LINE WAS POORLY CONNECTED. WHEN PURGING THE INJECTION SYSTEM, AIR WAS IDENTIFIED BY THE MEDICAL STAFF AT THE JUNCTION OF THE NON-RETURN VALVE DURING A CONTRAST INJECTION. A NEW K09 DEVICE WAS PREPARED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE FOR THIS PATIENT. NO MEDICAL INTERVENTION/MEDICATIONS DEEMED NECESSARY. NO PATIENT INJURIES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683474 MERIT CUSTOM KIT CUSTOM KIT OEQ MERIT MEDICAL SYSTEMS INC. H2002477 00884450236642

    Patients

    Seq Age Sex Outcome Treatment
    1