MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-26 for GHIATAS BEADED BREAST LOCALIZATION WIRE 477201 manufactured by Bard Peripheral Vascular, Inc..
[76160394]
The affected product catalog number, lot number and failure mode combination has been classified by the fda as a class ii recall, z-1900-2017. Manufacturing review: a lot history review was conducted, which indicated that a device history record (dhr) review was not required. Visual inspection: a visual inspection was not performed as the sample was not returned. Functional/performance evaluation: functional testing was not performed as the sample was not returned medical records review: a medical records review was not performed as no medical records were provided. Image/photo review: images were provided for review. Based on the images review, the reported artifact can be confirmed. Conclusion: although the sample was not returned for evaluation, images were provided for review. Based on the images review, the reported artifact can be confirmed. Therefore, the investigation is confirmed for the reported event. The definitive root cause could not be determined based upon available information. It is unknown whether procedural factors contributed to the event. Labeling review: a labeling review was not performed. H11:section a through f - 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
[76160395]
It was reported that allegedly during a breast localization wire placement into normal tissue density, the health care provider was unable to confirm the placement of the wire because of the alleged blooming artifact from the wire. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00529 |
| MDR Report Key | 6596021 |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-26 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2017-05-02 |
| Device Manufacturer Date | 2014-03-18 |
| Date Added to Maude | 2017-05-26 |
| 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 |
| Removal Correction Number | Z-1900-2017 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GHIATAS BEADED BREAST LOCALIZATION WIRE |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2017-05-26 |
| Catalog Number | 477201 |
| Lot Number | REYB1777 |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-05-26 |