MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for BD PHASEAL? INJECTOR LUER LOCK N35 515003 manufactured by Becton Dickinson, S.a..
[113004497]
(b)(6). 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
[113004498]
It was reported that the bd phaseal? Injector luer lock n35 experienced leakage when transferring the p14 and the n35. The user observed bubbles in the syringe with 1ml of fluid and it looks strange. They noticed a few drops on the gloves and on the outside of the phaseal? Components. No report of serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2018-00259 |
| MDR Report Key | 7652512 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-06-10 |
| Device Manufacturer Date | 2017-06-02 |
| Date Added to Maude | 2018-06-29 |
| 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? INJECTOR LUER LOCK N35 |
| Generic Name | PHASEAL INJECTOR |
| Product Code | ONG |
| Date Received | 2018-06-29 |
| Catalog Number | 515003 |
| Lot Number | 1705110 |
| Device Expiration Date | 2019-10-31 |
| 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 | CAMINO DE VALDEOLIVIA S/N SAN AGUSTIN DE GUADALIX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-29 |