BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3944072 · Received May 1, 2014

    Report

    Report Number
    1125782-2014-00004
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. MERIT IS UNABLE TO DETERMINE A ROOT CAUSE WITHOUT THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS NOT EXPECTED TO RETURN FOR EVAL. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THERE IS A SMALL HOLE IN THE CLEAR FILM MATERIAL OF THE PACKAGE CAUSING A BREACH IN THE STERILE BARRIER. THIS WAS DISCOVERED AT PREP AND THE KIT WAS NOT USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262062 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. T578172

    Patients

    Seq Age Sex Outcome Treatment
    1