BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER

    MDR report key: 10261345 · Received July 10, 2020

    Report

    Report Number
    2020394-2020-04386
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Report Date
    January 27, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: OF THE REPORTED TWELVE MALFUNCTIONS, ONE MALFUNCTION WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDR 2020394-2022-90029 H10: OF THE REMAINING ELEVEN MALFUNCTIONS, LOT NUMBERS WERE PROVIDED FOR SIX MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. HOWEVE, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR ALL ELEVEN MALFUNCTIONS. THEREFORE, FOR NINE MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND FOR TWO MALFUNCTIONS THE INVESTIGATION IS INCONCLUSIVE FOR PERFORATION. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ELEVEN MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF320J VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL ELEVEN MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE ELEVEN PATIENTS, EIGHT WERE MALE AND THREE WERE FEMALE, TEN PATIENTS AGE RANGED FROM 41-84 YEARS AND THREE WEIGHS IN THE RANGE BETWEEN 170-264 POUNDS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    FOR THE TWELVE MALFUNCTIONS, 7 LOT NUMBERS WERE PROVIDED AND LOT HISTORY REVIEWS WILL BE PERFORMED. NONE OF THE DEVICES WERE RETURNED FOR EVALUATION, HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR ALL OF THE MALFUNCTIONS. TEN OF THE INVESTIGATIONS ARE CONFIRMED FOR PERFORATION AND TWO ARE INCONCLUSIVE FOR THE ISSUE. THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. (CORPORATE LOT NUMBER: GFPI4170, GFSG3660, GFRK2287, GFPK1240, UNKNOWN).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES TWELVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF320J VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OFF THE TWELVE MALFUNCTIONS, ALL INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. EIGHT OF THE PATIENTS ARE MALE AND FOUR ARE FEMALE. ELEVEN PATIENTS' AGES RANGED FROM 41 - 84 YEARS. TWO PATIENTS' WEIGHTS WERE (B)(6) POUNDS. THE REMAINING PATIENTS' AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721836 G2 FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFTB3663, GFQA1501, GFBE4296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown