HAWKINS II BLN (BREAST LOCALIZATION NEEDLE)
Received Jul 25, 2018 · Event occurred Jun 6, 2018
Report 1625425-2018-00080 · MDR key 7719922
Device
Generic name
Breast Localization Needle
Manufacturer
Argon Medical Devices Inc.Catalog number
252050
Lot number
11180055
Product problems
- Break
- Component Missing
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
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
THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.
Description of Event or Problem
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.