BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1120044 · Received August 15, 2008

    Report

    Report Number
    2020394-2008-00227
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 18, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MANUFACTURING LOT NUMBER. THE SAMPLE WAS RETURNED FOR EVAL AND THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IVC FILTER DID NOT COMPLETELY DEPLOY. THE TECH REPORTED THAT THE PHYSICIAN TENDS TO DEPLOY SLOWLY. THE PHYSICIAN REMOVED THE SYSTEM AND COMPLETED THE PROCEDURE USING ANOTHER FEMORAL IVC FILTER FOR A SUCCESSFUL PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFSE2801

    Patients

    Seq Age Sex Outcome Treatment
    1