MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-20 for GHIATAS LOCALIZATION WIRE 479201 manufactured by Bard Peripheral Vascular, Inc..
[177837666]
The lot number was provided for the one malfunction; therefore, a lot history review is currently being performed. The device was returned for evaluation and the company is still investigating the issue at this time.
Patient Sequence No: 1, Text Type: N, H10
[177837667]
This report summarizes the one malfunction. A review of the reported information indicated that model 479201 breast localization wire allegedly experienced signal artifact. This information was received from one source. Of the one signal artifact, one involved a patient with no patient consequences. The patient information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00655 |
| MDR Report Key | 9607032 |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GHIATAS LOCALIZATION WIRE |
| Generic Name | BREAST LOCALIZATION WIRE |
| Product Code | GDF |
| Date Received | 2020-01-20 |
| Model Number | 479201 |
| Catalog Number | 479201 |
| Lot Number | REBW1089 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-20 |