BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 FILTER SYSTEM - JUGULAR

    MDR report key: 3933754 · Received April 3, 2014

    Report

    Report Number
    2020394-2014-00121
    Event Type
    Death
    Date Received
    April 3, 2014
    Date of Event
    December 30, 2009
    Report Date
    December 16, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME AFTER IMPLANTATION OF A VENACAVA FILTER, FILTER FRACTURE WAS DISCOVERED. THE FILTER WAS REMOVED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200354 G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Death