MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-24 for BD PHASEAL OPTIMA INJECTOR (N35-O) 515052 manufactured by Becton Dickinson, S.a..
| Report Number | 3002682307-2020-00062 |
| MDR Report Key | 9748304 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-24 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-08-27 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON, S.A. |
| Manufacturer Street | CR MEQUINENZA S/N |
| Manufacturer City | FRAGA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PHASEAL OPTIMA INJECTOR (N35-O) |
| Generic Name | INTRAVASACULAR ADMINISTRATION SET |
| Product Code | ONB |
| Date Received | 2020-02-24 |
| Catalog Number | 515052 |
| Lot Number | 1908105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON, S.A. |
| Manufacturer Address | CR MEQUINENZA S/N FRAGA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |