HAWKINS II BLN (BREAST LOCALIZATION NEEDLE)
Received May 28, 2014 · Event occurred Apr 24, 2014
Report 1625425-2014-00017 · MDR key 3854900
Device
Product problems
- Break
Patient
UNK
- Tissue Damage
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
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.