BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 4973351 · Received August 5, 2015

    Report

    Report Number
    1721504-2015-00138
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    DQO
    PMA / PMN Number
    K031691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION. ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE DEVICE WAS BROKEN INTO TWO PIECES. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE OF THE BREAKAGE IS EXCESSIVE FORCE BEING APPLIED TO THE WIRE DURING USE. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED.

    Additional Manufacturer Narrative · 1

    ONE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A SHUTAGRAM ON THE PATIENT'S ARM, THE TIP OF THE WIRE SEPARATED FROM THE SHAFT AND REMAINED IN THE PATIENT AFTER THE WIRE WAS WITHDRAWN. THE TIP OF THE WIRE WAS FOUND AND REMOVED WITH A SNARE. THE WIRE WAS REPLACED AND THE CASE CONTINUED. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513866 MERIT CUSTOM KIT CUSTOM KIT DQO MERIT MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention