BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM DISPOSABLE CORE BIOPSY NEEDLE

    MDR report key: 3101829 · Received May 1, 2013

    Report

    Report Number
    2020394-2013-00130
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    December 12, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FCG
    PMA / PMN Number
    K934370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOPSY NEEDLE IN THE UNOPENED PACKAGE APPEARED TO BE LONGER THAN THE LABELED LENGTHY OF 10CM. EVALUATION OF THE RETURNED DEVICE REVEALED THE NEEDLE WAS 13CM. THE NEEDLE WAS NOT USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190371 MAGNUM DISPOSABLE CORE BIOPSY NEEDLE FCG BARD PERIPHERAL VASCULAR, INC. REWE1689

    Patients

    Seq Age Sex Outcome Treatment
    1