MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for GHIATAS LOCALIZATION WIRE 47720 manufactured by Bard Peripheral Vascular, Inc..
[174535133]
The devices for the two malfunctions have been returned to the manufacturer for evaluation. The investigations of the reported malfunctions are currently underway. The devices are labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[174535234]
This report summarizes two malfunctions. A review of the reported information indicated that model 47720 biopsy instrument allegedly experienced device markings issue. This information was received from various sources. Both malfunctions had no reported patient involvement. The patients? Age, weight, and sex were not provided for either malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00183 |
| MDR Report Key | 9572361 |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-01-09 |
| 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 | BIOPSY INSTRUMENT |
| Product Code | GDF |
| Date Received | 2020-01-09 |
| Model Number | 47720 |
| Catalog Number | 47720 |
| Lot Number | REDN4349,REDQ1624 |
| 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 | 2020-01-09 |