BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 11882105 · Received May 25, 2021

    Report

    Report Number
    1721504-2021-00037
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OEQ
    UDI-DI
    00884450298022
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING A PCI PROCEDURE, THE MANIFOLD KIT PULLED AIR IN THROUGH THE TUBING AND SYRINGE. NO ADVERSE EVENT OR INJURY OCCURRED AS NO AIR WAS INJECTED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771186 MERIT CUSTOM KIT CUSTOM KIT OEQ MERIT MEDICAL SYSTEMS INC. 00884450298022 00884450298022

    Patients

    Seq Age Sex Outcome Treatment
    1