HAWKINS III BLN (BREAST LOCALIZATION NEEDLE)
Received Oct 20, 2016 · Event occurred Jun 9, 2014
Report 1625425-2016-00070 · MDR key 6045799
Device
Generic name
Breast Localization Needle
Catalog number
244100
Lot number
UNKNOWN
Product problems
- Material Fragmentation
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT AVAILABLE FOR RETURN; THEREFORE, NO DEVICE EVALUATION COULD BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED. WITHOUT A SAMPLE TO EVALUATE OR A LOT NUMBER AVAILABLE TO CONDUCT DEVICE HISTORY RECORD REVIEWS, A ROOT CAUSE CANNOT BE ESTABLISHED. (B)(4).
Description of Event or Problem
THE TIP OF THE HAWKINS GUIDEWIRE FRAGMENTED AND WAS RETAINED WITHIN A PATIENT'S BREAST. THE V SHAPE OF THE GUIDEWIRE TIP CONTRIBUTED TO NOT DETECTING FRAGMENTATION ON THE SPECIMEN X-RAY. THE PATIENT REQUIRED FURTHER SURGERY TO TO HAVE THE TIP OF THE GUIDEWIRE REMOVED FROM THEIR BREAST.