BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLEPLAY HEMOSTASIS VALVE

    MDR report key: 5032270 · Received August 26, 2015

    Report

    Report Number
    9616662-2015-00010
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MERIT MEDICAL IRELAND LTD.
    Product Code
    DTL
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND A WRINKLE WAS OBSERVED IN THE SEAL. A BREACH TEST WAS PERFORMED AND NO BREACH WAS FOUND IN THE PACKAGING. THE COMPLAINT IS UNCONFIRMED. 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.

    Additional Manufacturer Narrative · 1

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

    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 DEVICE WAS NOT SENT TO A USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563705 DOUBLEPLAY HEMOSTASIS VALVE HEMOSTASIS VALVE DTL MERIT MEDICAL IRELAND LTD. K742804

    Patients

    Seq Age Sex Outcome Treatment
    1