BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE

    MDR report key: 2943833 · Received January 30, 2013

    Report

    Report Number
    2020394-2013-00020
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FCG
    PMA / PMN Number
    K936194
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE COAXIAL NEEDLE AFTER A LUMBAR DISC BIOPSY, THE NEEDLE WAS NOTED TO HAVE DETACHED INTO TWO PIECES AND THE DISTAL SEGMENT REMAINED IN THE PT. THE INCISION AT THE SKIN WAS SLIGHTLY ENLARGED AND THE DETACHED DISTAL SEGMENT WAS SUCCESSFULLY REMOVED WITH FORCEPS. THE CURRENT PT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39986 TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE FCG BARD PERIPHERAL VASCULAR, INC. REWE1477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention