MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for BD PHASEAL? PROTECTOR P50J 515111 manufactured by Becton Dickinson, S.a..
[95816875]
Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[95816876]
It was reported during use of the bd phaseal? Protector p50j when preparing vincristine sulfate (chemo), it leaked from the connection of the vial and the protector. There was no report of injury or medical intervention
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2017-00204 |
| MDR Report Key | 7133908 |
| Date Received | 2017-12-20 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-12-20 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON, S.A. |
| Manufacturer Street | CAMINO DE VALDEOLIVIA S/N |
| Manufacturer City | SAN AGUSTIN DE GUADALIX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD PHASEAL? PROTECTOR P50J |
| Generic Name | PHASEAL INJECTOR |
| Product Code | ONG |
| Date Received | 2017-12-20 |
| Returned To Mfg | 2017-12-20 |
| Catalog Number | 515111 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON, S.A. |
| Manufacturer Address | CAMINO DE VALDEOLIVIA S/N SAN AGUSTIN DE GUADALIX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-20 |