MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-04 for BD PHASEAL? OPTIMA INJECTOR (N35-O) 515052 manufactured by Becton Dickinson, S.a..
| Report Number | 3003152976-2020-00037 |
| MDR Report Key | 9666522 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-04 |
| 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 | CAMINO DE VALDEOLIVIA S/N |
| Manufacturer City | SAN AGUSTIN DE GUADALIX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PHASEAL? OPTIMA INJECTOR (N35-O) |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | ONB |
| Date Received | 2020-02-04 |
| Catalog Number | 515052 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON, S.A. |
| Manufacturer Address | CAMINO DE VALDEOLIVIA S/N SAN AGUSTIN DE GUADALIX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |