BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 10824264 · Received November 11, 2020

    Report

    Report Number
    1721504-2020-00094
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 14, 2020
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OJA
    UDI-DI
    00884450183113
    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 BUBBLE TESTING WAS PERFORMED. THE COMPLAINT IS CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY, AND FUNCTIONAL TESTING WAS PERFORMED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. 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 · 1

    THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION, OR INJURY TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290821 MERIT CUSTOM KIT CUSTOM ANGIOGRAPHIC KIT OJA MERIT MEDICAL SYSTEMS INC. H1858919 00884450183113

    Patients

    Seq Age Sex Outcome Treatment
    1