MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-30 for MR GHIATAS BEADED BREAST LOCALIZATION WIRE 477201 manufactured by Bard Peripheral Vascular, Inc..
[109572145]
No medical records were provided to the manufacturer, but photos and medical images were provided. The lot number for the device was provided. The device history records are currently under review. The device has been returned for evaluation. The investigation of the reported event is currently underway. (02/2018). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[109572146]
It was reported that post placement of a localization wire, an artifact allegedly was found on mr imaging. The localization wire reportedly was non-mr and incorrectly packaged with mr labeling. It was further reported that the procedure was completed with the same wire. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-00749 |
| MDR Report Key | 7554246 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-30 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2018-02-27 |
| Date Added to Maude | 2018-05-30 |
| 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 | 1625 W 3RD ST. |
| 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 | MR GHIATAS BEADED BREAST LOCALIZATION WIRE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | GDF |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-11 |
| Model Number | 477201 |
| Catalog Number | 477201 |
| Lot Number | RECN2448 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-30 |