MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-20 for BD?PHASEAL? INJECTOR LUER LOCK N35C 515004 manufactured by Becton Dickinson, S.a..
[103178123]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1712001. Medical device expiration date: 2020-05-31. Device manufacture date: 2017-12-27. Medical device lot #: 1709003. Medical device expiration date: 2020-02-29. Device manufacture date: 2017-10-16. 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
[103178124]
It was reported that when storing a bd phaseal? Injector luer lock n35c (connected to a pastipak syringe) in the refrigerator for two days, there was presence of chemotherapy drops in the cap, showing the lack of watertight seal of the system. There was no report of exposure, injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2018-00101 |
| MDR Report Key | 7356088 |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-03-20 |
| 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? INJECTOR LUER LOCK N35C |
| Generic Name | INJECTOR |
| Product Code | ONG |
| Date Received | 2018-03-20 |
| Catalog Number | 515004 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| 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 | 2018-03-20 |