BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER

    MDR report key: 8826677 · Received July 25, 2019

    Report

    Report Number
    2020394-2019-01876
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Report Date
    July 25, 2019
    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 · 1

    THE MEDICAL RECORDS FOR BOTH EVENTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. BOTH INVESTIGATIONS ARE CONFIRMED FOR FILTER TILT AND RETRIEVAL DIFFICULTIES. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN FOR BOTH INVESTIGATIONS. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL MD800J VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULTY DURING REMOVAL AND MALPOSITION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS INVOLVED PATIENTS WITHOUT CONSEQUENCE. ONE PATIENT WAS REPORTED TO BE A (B)(6) YEAR-OLD MALE WEIGHING (B)(6) KGS. THE SECOND WAS REPORTED TO BE A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) KGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622109 MERIDIAN FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFVK0306,GFXD3877

    Patients

    Seq Age Sex Outcome Treatment
    1