MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-30 for HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) 242050 manufactured by Argon Medical Devices Inc..
[4589953]
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.
Patient Sequence No: 1, Text Type: D, B5
[11999673]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2014-00018 |
| MDR Report Key | 3877787 |
| Report Source | 06 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2014-05-02 |
| Device Manufacturer Date | 2014-03-27 |
| Date Added to Maude | 2014-06-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK RD. |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 9722102562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) |
| Generic Name | NONE |
| Product Code | GDM |
| Date Received | 2014-05-30 |
| Returned To Mfg | 2014-05-02 |
| Catalog Number | 242050 |
| Lot Number | 11063213 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | ATHENS TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-30 |