BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKINS II BLN (BREAST LOCALIZATION NEEDLE)

    MDR report key: 3854900 · Received May 28, 2014

    Report

    Report Number
    1625425-2014-00017
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    GDM
    PMA / PMN Number
    K870523
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED DEVIATIONS OR ABNORMALITIES FOR THE COMPLAINT LOT NUMBER 11061821. THERE WAS ONE OTHER SIMILAR COMPLAINT FOR THIS PRODUCT FROM THE SAME DOCTOR. BEFORE THESE TWO COMPLAINTS, THERE WERE NO OTHER PRIOR SIMILAR COMPLAINTS FOR LOT 11061821 OR 11063213 WHICH BOTH CONTAINED THE SAME SUB (WIRE) LOT. THE ROOT CAUSE OF THE BREAKAGE OF THE BREAST LOCALIZATION NEEDLE WAS NOT DETERMINED. THE RETURNED NEEDLE WAS BROKEN. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    DR (B)(6), PROCEEDED TO DEPLOY THE WIRE THROUGH THE END HOLE AND NOTICED THAT HE DID NOT FEEL IT LOCK INTO PLACE. HE THEN REALIZED THAT THE END OF THE HOOK BROKE OFF FROM THE WIRE. HE THEN PLACED ANOTHER NEEDLE/WIRE INTO THE BREAST. THE PATIENT NEEDED TO HAVE MORE TISSUE REMOVED TO MAKE SURE THE BROKEN PIECE OF WIRE FROM THE HAWKINS II NEEDLE WAS EXCISED WITH THE ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315167 HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) GDM ARGON MEDICAL DEVICES INC. 11061821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention