BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAWKINS II BLN (BREAST LOCALIZATION NEEDLE)

    MDR report key: 7719922 · Received July 25, 2018

    Report

    Report Number
    1625425-2018-00080
    Event Type
    Death
    Date Received
    July 25, 2018
    Date of Event
    June 6, 2018
    Report Date
    August 20, 2018
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    GDM
    PMA / PMN Number
    K870523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN UPDATE FROM THE CUSTOMER STATES THAT A FOLLOW-UP SCAN WAS NOT CONDUCTED ON THE PATIENT. A REVIEW OF RETURNED PRODUCT FROM THE CUSTOMER WAS PERFORMED. THE NEEDLE WAS RETURNED IN TWO PIECES AND ONE PIECE OF THE BROKEN WIRE WAS RETURNED. THE COMBINED LENGTH OF THE NEEDLE PIECES WERE MEASURED TO BE 50MM (5CM). THE PIECE OF THE WIRE THAT WAS RETURNED MEASURED 43MM (4.3CM) IN LENGTH. ACCORDING TO THE SAMPLE INVESTIGATION, THE NEEDLE WAS MOST LIKELY BENT DURING OR AFTER THE PROCEDURE. ATTEMPTS TO STRAIGHTEN THE NEEDLE CAUSED THE NEEDLE TO BREAK INTO TWO PIECES. INSPECTION OF THE WIRE INDICATES THAT THE WIRE WAS CUT FROM ONE SIDE CLOSE TO THE MARK ON THE WIRE. ALTHOUGH THE EXACT CAUSE OF THE ISSUE CANNOT BE DETERMINED, THE ISSUE OCCURRED DUE TO AN EVENT DURING THE USE OF THE PRODUCT. SINCE THERE ARE NO ATTRIBUTABLE MANUFACTURING OR DESIGN ISSUES, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    BREAST SURGEONS REMOVED THE DEVICE FROM A PATIENT (HAS DONE THIS PROCEDURE WITH THIS DEVICE MANY TIME). UPON REMOVAL, NOTICED THE HOOK MISSING. THE TEAM AT THE HOSPITAL ARE ARRANGING A SCAN TO SEE IF THE HOOK HAS BEEN RETAINED IN THE PATIENT OR BROKE OFF DURING INSERTION OR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560486 HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) BREAST LOCALIZATION NEEDLE GDM ARGON MEDICAL DEVICES INC. 11180055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other