BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKINS II BLN (BREAST LOCALIZATION NEEDLE)

    MDR report key: 3877787 · Received May 30, 2014

    Report

    Report Number
    1625425-2014-00018
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 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 11063213. 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 11063213 OR 1106182 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 INSERTED THE NEEDLE INTO THE PT UNDER FLUOROSCOPY TO INTRODUCE THE HAWKINS II NEEDLE, HOOK/WIRE. HE ADVANCED THE WIRE TO THE TIP OF THE NEEDLE AND BACKED THE WIRE/HOOK UP, THUS TO TAKE ONE FINAL PLACEMENT MARKING AND PREPARE FOR THE HOOK OF THE WIRE TO BE INSERTED INTO THE MASS OF THE BREAST WITH THE WIRE HANGING OUT OF THE PT. WHEN THE WIRE WAS BEING PULLED BACK, THE WIRE CAME APART FROM THE HOOK PORTION OF THE TOTAL HOOK/WIRE DEVICE AND THE DOCTOR WAS LEFT HOLDING THE WIRE (NO HOOK) IN HIS HAND. DR (B)(6) THEN SET THE WIRE PORTION ASIDE AND OPENED ANOTHER HAWKINS II NEEDLE PACKAGE AND USED THE SECOND WIRE/HOOK PORTION TO ADVANCE DOWN THE PREVIOUS NEEDLE. THE NEW WIRE/HOOK END WAS MET WITH RESISTANCE. DR (B)(6) THEN ADVANCED THE SECOND HOOK/WIRE AND PUSHED THE DETACHED HOOK INTO THE PT. THE SECOND WIRE WAS INSERTED INTO THE PT, SO THE MASS COULD BE MARKED OR REMOVED. THE HOOK COULD NOT BE LOCATED WITHIN THE PT AND THE PT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE HOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319445 HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) NONE GDM ARGON MEDICAL DEVICES INC. 11063213

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention