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 2020-01-29 for VENAFLO VASCULAR GRAFT V4007C manufactured by Bard Peripheral Vascular, Inc..
[176972759]
The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The results of the anticipated device evaluation will be provided upon completion of the event investigation. The information provided by bd 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 bd.
Patient Sequence No: 1, Text Type: N, H10
[176972760]
It was reported that some time post graft placement the patient experienced thrombosis of an avf brachia-cephalic at the elbow. It was further reported that the physician performed a partial excision and interpolate the graft at the arterial puncture site. Reportedly, the patient experienced an infection some time post placement and was treated with an iv injection. After the iv injection the patient experienced a reaction at the puncture site. The health care provider decided to remove the graft from the patient. Patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00830 |
| MDR Report Key | 9644805 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-12-29 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2018-07-18 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Catalog Number | V4007C |
| Lot Number | VTCU0303 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-01-29 |