MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-11 for BD PHASEAL? Y-SITE CONNECTOR C80 515304 manufactured by Becton Dickinson, S.a..
[188811799]
Date of event: unknown. The date received by manufacturer has been used for this field. 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
[188811800]
It was reported that the bd phaseal? Y-site connector c80 leaked from the nozzle during use. The following information was provided by the initial reporter, translated from (b)(6) to english: "leakage at the rince nozzle, it's recurring"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2020-00049 |
| MDR Report Key | 9694513 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-02-11 |
| 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? Y-SITE CONNECTOR C80 |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | ONB |
| Date Received | 2020-02-11 |
| Model Number | 515304 |
| Catalog Number | 515304 |
| Lot Number | 1905101 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-11 |