BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKINS II

    MDR report key: 3901589 · Received May 12, 2014

    Report

    Report Number
    3901589
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    GDM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE NEEDLE LOCALIZATION PROCEDURE, USING HAWKINS II NEEDLE DURING ROUTINE PASSAGE OF WIRE OUT END OF NEEDLE TO LOCK (SECURE) IN PLACE, THE WIRE BROKE OFF UNEXPECTEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284585 HAWKINS II 20 GAUGE 5 CM NEEDLE LOCALIZATION WIRE GDM ARGON MEDICAL DEVICES 11061821

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention