BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER

    MDR report key: 9216513 · Received October 21, 2019

    Report

    Report Number
    2020394-2019-04240
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    January 22, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: OF THE 7 DEVICES, 4 LOT NUMBERS WERE PROVIDED, AND THE LOT HISTORY REVIEWS WERE PERFORMED. OF THE SEVEN REPORTED MALFUNCTIONS, NONE OF THE DEVICES WERE RETURNED. 7 OF THE MALFUNCTIONS PROVIDED MEDICAL RECORDS AND 2 OF THE MALFUNCTIONS PROVIDED IMAGES. THE INVESTIGATION IDENTIFIED THAT PATIENT DEVICE INTERACTION PROBLEM WAS CONFIRMED FOR 5 MALFUNCTIONS, TILT WAS INCONCLUSIVE FOR 6 DEVICES, PATIENT DEVICE INTERACTION WAS INCONCLUSIVE FOR 2 MALFUNCTIONS FOR ONE DEVICE, TRENDING DEVICE CODE HAS BEEN UPDATED (4001 - PATIENT DEVICE INTERACTION PROBLEM). A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: GFXB3197). 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.

    Additional Manufacturer Narrative · 0

    H10: OF THE 7 DEVICES, 4 LOT NUMBERS WERE PROVIDED, AND THE LOT HISTORY REVIEWS WERE PERFORMED. OF THE SEVEN REPORTED MALFUNCTIONS, NONE OF THE DEVICES WERE RETURNED. SEVEN OF THE MALFUNCTIONS PROVIDED MEDICAL RECORDS AND THREE OF THE MALFUNCTIONS PROVIDED IMAGES. FOR THREE MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT. FOR ONE MALFUNCTION, THE INVESTIGATION IS CONFIRMED FOR FILER TILT AND PERFORATION OF THE IVC. FOR TWO MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR FILTER TILT. FOR ONE MALFUNCTION, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION OF THE IVC AND FILTER TILT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELLED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: GFXB3197, UNKNOWN). 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 SEVEN MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL MD800F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SEVEN REPORTED MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. ALL SEVEN MALFUNCTIONS PROVIDED PATIENT INFORMATION. THE PATIENT AGES RANGE FROM 46 TO 78 YEARS. SIX PATIENTS ARE MALE, ONE FEMALE. THE PATIENT WEIGHTS RANGING FROM 241-275 LBS.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES SEVEN MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL MD800F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT DEVICE INTERACTION PROBLEM AND MALPOSITION OF DEVICE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SEVEN REPORTED MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. THE SEVEN PATIENT AGES RANGE FROM 46 TO 78 YEARS. SIX PATIENTS ARE MALE, ONE WAS FEMALE. TWO PATIENT WEIGHTS RANGING FROM 241-275 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    OF THE 7 DEVICES, 4 LOT NUMBERS WERE PROVIDED, AND THE LOT HISTORY REVIEWS WERE PERFORMED. OF THE SEVEN REPORTED MALFUNCTIONS, NONE OF THE DEVICES WERE RETURNED. 7 OF THE MALFUNCTIONS PROVIDED MEDICAL RECORDS AND 3 OF THE MALFUNCTIONS PROVIDED IMAGES. PERFORATION WAS CONFIRMED FOR 2 DEVICES AND INCONCLUSIVE FOR FILTER TILT. PERFORATION AND FILTER TILT WERE INCONCLUSIVE FOR 2 DEVICES. THE COMPANY IS STILL INVESTIGATING THIS ISSUE FOR 3 DEVICES, WHICH ALL HAVE IMAGES AND MEDICAL RECORDS. A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE. (CORPORATE LOT NUMBER: GFXB3197).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES SEVEN MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL MD800F VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE/TILT AND PATIENT DEVICE INTERACTION PROBLEM/PERFORATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SEVEN REPORTED MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. ALL SEVEN MALFUNCTIONS PROVIDED PATIENT INFORMATION. THE PATIENT AGES RANGE FROM 46 TO 78 YEARS. SIX PATIENTS ARE MALE, ONE FEMALE. THE PATIENT WEIGHTS RANGING FROM 241-275 LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008300 MERIDIAN FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFXA3827, GFWA0037, GFXA3845

    Patients

    Seq Age Sex Outcome Treatment
    1