BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILIZED CONVENIENCE KIT

    MDR report key: 5033685 · Received August 26, 2015

    Report

    Report Number
    1125782-2015-00024
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    February 13, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND A BREACH IN THE STERILE BARRIER WAS IDENTIFIED. THE COMPLAINT IS CONFIRMED. THE SCISSORS IN THE KIT HAVE A SHARP POINT AND CAUSED A HOLE IN THE PACKAGING. A PROTECTIVE WRAP HAS BEEN ADDED TO THE KIT TO PREVENT THIS FROM REOCCURRING. 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 A DEFECT IN THE PACKAGING. THIS DAMAGE WAS DISCOVERED WHEN THE KIT WAS TAKEN OUT OF THE SHIPPING BOX. THE KIT WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565112 STERILIZED CONVENIENCE KIT CONVENIENCE KIT KDD MERIT MEDICAL SYSTEMS, INC. T775648

    Patients

    Seq Age Sex Outcome Treatment
    1