MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for VENAFLO VASCULAR GRAFT VLT2547C manufactured by Bard Peripheral Vascular, Inc..
[180324750]
The lot number was provided for the reported malfunction and a lot history review was performed. A device was not returned for evaluation, but one electronic photo was provided. The investigation was inconclusive for the reported device markings issue. A root cause could not be determined. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[180324751]
This report summarizes one malfunction. The information received indicated that model vlt2547c vascular graft allegedly experienced device markings issue. This information was received from one source. The malfunction involve a patient with no reported consequences. Age, weight, and gender were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00226 |
| MDR Report Key | 9587435 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-14 |
| 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 PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENAFLO VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-01-14 |
| Model Number | VLT2547C |
| Catalog Number | VLT2547C |
| Lot Number | VTCT0517 |
| 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 | 2020-01-14 |