MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-12 for HAWKINS II manufactured by Argon Medical Devices.
[4650269]
During routine needle localization procedure, using hawkins ii needle routine passage of wire out end of needle to lock (secure) in place, the wire broke off unexpectedly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3901590 |
| MDR Report Key | 3901590 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-05-01 |
| Date Facility Aware | 2014-05-01 |
| Report Date | 2014-05-01 |
| Date Reported to Mfgr | 2014-05-01 |
| Date Added to Maude | 2014-07-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINS II |
| Generic Name | 20 GAUGE 5 CM NEEDLE LOCALIZATION WIRE |
| Product Code | GDM |
| Date Received | 2014-05-12 |
| Lot Number | 11063213 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES |
| Manufacturer Address | 5600 TENNYSON PKWY. 335 PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-12 |