BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KITS

    MDR report key: 10483306 · Received September 2, 2020

    Report

    Report Number
    1721504-2020-00065
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 12, 2020
    Report Date
    August 26, 2020
    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 · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. 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. CORRECTIVE ACTIONS ARE IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    ACCOUNT ALLEGES THAT THERE IS A FOREIGN OBJECT WITHIN THE FLUID PATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948293 MERIT CUSTOM KITS INTRAVENOUS EXTENSION TUBING SET KIT OJA MERIT MEDICAL SYSTEMS INC. H1858980

    Patients

    Seq Age Sex Outcome Treatment
    1