BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 900909 · Received August 21, 2007

    Report

    Report Number
    2020394-2007-00247
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Report Date
    July 31, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNK. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION SUBMITTED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. THE 510K NUMBER FOR THE FEMORAL FILTER IS K062887 AND IS K052578 FOR THE JUGULAR FILTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERFORATION. SEVERAL UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR