MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-28 for HAWKINS II BLN (BREAST LOCALIZATION NEEDLE) 242050 manufactured by Argon Medical Devices Inc..
[4616533]
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.
Patient Sequence No: 1, Text Type: D, B5
[12163479]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2014-00017 |
| MDR Report Key | 3854900 |
| Report Source | 06 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-27 |
| Date of Event | 2014-04-24 |
| Date Mfgr Received | 2014-04-28 |
| Device Manufacturer Date | 2014-03-06 |
| Date Added to Maude | 2014-06-10 |
| 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) |
| Product Code | GDM |
| Date Received | 2014-05-28 |
| Returned To Mfg | 2014-05-02 |
| Catalog Number | 242050 |
| Lot Number | 11061821 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-05-28 |