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.
[16088481]
During routine needle localization procedure, using hawkins ii needle during 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 | 3901574 |
| MDR Report Key | 3901574 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-04-10 |
| Date Facility Aware | 2014-04-10 |
| Report Date | 2014-05-01 |
| Date Reported to Mfgr | 2014-04-25 |
| 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 5CM NEEDLE LOCALIZATION WIRE |
| Product Code | GDM |
| Date Received | 2014-05-12 |
| Lot Number | 11061821 |
| 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. STE 335 PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-12 |