BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILIZED CONVENIENCE KIT

    MDR report key: 4173461 · Received October 10, 2014

    Report

    Report Number
    9616662-2014-00012
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: NO DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED AND AN ADDITIONAL FOLLOW UP SUBMITTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING THE USER OF A CONVENIENCE KIT IN AN EMERGENT CASE, THE PLASTIC PART OF THE DRAPE SEPARATED FROM THE WOVEN PART. THIS RESULTED IN A CONTAMINATION OF THE STERILE FIELD. THE PROCEDURE WAS DELAYED BY TEN MINUTES TO RE-PREP THE STERILE FIELD. NO HARM OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642621 STERILIZED CONVENIENCE KIT KIT, SURGICAL INSTRUMENT, DESPOSABLE KDD MERIT MEDICAL SYSTEMS, INC. K677551

    Patients

    Seq Age Sex Outcome Treatment
    1