BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 5980490 · Received September 27, 2016

    Report

    Report Number
    1721504-2016-00189
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Removal / Correction Number
    1721504-09/22/16-005R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR RETURNED 119 UNITS FOR EVALUATION. A SAMPLE OF UNITS WERE EXAMINED VISUALLY. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. 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. CORRECTIVE ACTIONS ARE IN PROCESS FOR THIS FAILURE MODE. MERIT DETERMINED ON (B)(6) 2016 THAT A PRODUCT REMOVAL WOULD BE REQUIRED FOR FOUR LOTS OF KITS AFFECTED BY THIS PACKAGING DEFECT. COMMUNICATIONS TO CONSIGNEES BEGAN ON (B)(6) 2016. A REPORT TO THE FDA IN ACCORDANCE WITH 21 CFR 806.10 IS IN PROCESS AND WILL BE SENT WITHIN THE TEN DAY REQUIREMENT OF INITIATING FIELD ACTION. NO ADDITIONAL 3500A FORMS WILL BE FILED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF RECEIVED PRODUCT. THE DEVICES WERE NOT SENT TO A USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631417 MERIT CUSTOM KIT CUSTOM KIT DQO MERIT MEDICAL SYSTEMS, INC H996433

    Patients

    Seq Age Sex Outcome Treatment
    1