BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 EXPRESS FILTER SYSTEM-JUGULAR

    MDR report key: 3851244 · Received March 25, 2014

    Report

    Report Number
    2020394-2014-00105
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 28, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEPLOYMENT OF A VENA CAVA FILTER, SOME FILTER LEGS WERE CROSSED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174154 G2 EXPRESS FILTER SYSTEM-JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFVH0135

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention