MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for HAWKINS NEEDLE II 252075 manufactured by Angiotech.
[28833467]
Patient was undergoing a left breast needle wire localization with sentinel node injection. Radiologist tested the needle and wire by moving them into each other before placing the wire into the patient's left breast. He placed the needle into the patient and when he was removing the needle to deploy the wire, the wire got pulled back with the needle. Radiologist had to start over with a new needle and wire causing the patient to have to undergo a second needle stick.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057169 |
| MDR Report Key | 5161638 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-10-09 |
| Date of Event | 2015-09-08 |
| Date Added to Maude | 2015-10-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HAWKINS NEEDLE II |
| Generic Name | HAWKINS NEEDLE II |
| Product Code | GDM |
| Date Received | 2015-10-09 |
| Model Number | 252075 |
| Catalog Number | 252075 |
| Device Expiration Date | 2018-10-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOTECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-09 |