MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for GHIATAS BEADED LOCALIZATION WIRE 47920 manufactured by Bard Peripheral Vascular, Inc..
[141024517]
The one device belonging to the sole complaint is expected to be returned to bd for evaluation. The company is still investigating the issue at this time.
Patient Sequence No: 1, Text Type: N, H10
[141024518]
This report summarizes one malfunction event. A review of the events indicated that model 47920 localization wire allegedly had foreign material on the needle, upon removal from the packaging. There was no patient involvement for this one event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-00224 |
| MDR Report Key | 8485173 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-10-08 |
| Date Mfgr Received | 2019-09-30 |
| Date Added to Maude | 2019-04-04 |
| 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 BEADED LOCALIZATION WIRE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | GDF |
| Date Received | 2019-04-04 |
| Model Number | 47920 |
| Catalog Number | 47920 |
| Lot Number | RECV2460 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-04-04 |