BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MONOPTY

    MDR report key: 3151829 · Received June 4, 2013

    Report

    Report Number
    MW5030456
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BARD PERITONEAL VASCULAR INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    BIOPSY GUN WAS ADVANCED THROUGH GUIDE NEEDLE AND DEPLOYED. IT WAS SOMEWHAT DIFFICULT TO REMOVE. ON SECOND DEPLOYMENT THE GUN WAS VERY DIFFICULT TO REMOVE AND THE GUIDE NEEDLE ADVANCED WITH THE DEPLOYMENT OF THE GUN. REASON FOR USE: RETROPERITONEAL LYMPH NODE BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247174 BARD MONOPTY DISPOSABLE CARE BIOPSY INSTRUMENT KNW BARD PERITONEAL VASCULAR INC. REV50386

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR