BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KITS

    MDR report key: 5003433 · Received August 14, 2015

    Report

    Report Number
    1125782-2015-00021
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SUSPECT UNIT WAS RETURNED FOR EVALUATION. THE TRAY WAS RETURNED OPENED WITHOUT THE HEADER BAG. A FULL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED PRODUCT. THE COMPLAINT COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    THE USER REPORTED THAT WHEN THE DEVICE WAS OPENED TO PREPARE FOR INITIAL USE IT WAS OBSERVED THAT THE PACKAGING HAD HOLES COMPROMISING THE STERILITY OF THE DEVICE. THIS WAS OBSERVED PRIOR TO USE. THIS DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538343 MERIT CUSTOM KITS CUSTOM KIT KDD MERIT MEDICAL SYSTEMS, INC. T782638

    Patients

    Seq Age Sex Outcome Treatment
    1