MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-26 for BARD VDA100164 manufactured by Bard Peripheral Vascular Inc..
| Report Number | 8936164 |
| MDR Report Key | 8936164 |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-08-16 |
| Date Facility Aware | 2019-08-19 |
| Report Date | 2019-08-21 |
| Date Reported to FDA | 2019-08-22 |
| Date Added to Maude | 2019-08-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD |
| Generic Name | VIDA PTV DILATATION CATHETER |
| Product Code | OMZ |
| Date Received | 2019-08-26 |
| Model Number | VDA100164 |
| Catalog Number | VDA100164 |
| Lot Number | 93X80155 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR INC. |
| Manufacturer Address | 1625 WEST 3RD STREET TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-26 |