MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for BD PHASEAL? INJECTOR LUER LOCK N35 515003 manufactured by Becton Dickinson, S.a..
[103437731]
Date of event: unknown. The date received by manufacturer has been used for this field. A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[103437732]
It was reported that foreign matter described as? White flakes/shreds? Were noticed in the medication vials when the drug from the vial was removed using a bd phaseal? Injector luer lock n35. There was no report of exposure, injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2018-00108 |
| MDR Report Key | 7364155 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-03-08 |
| Device Manufacturer Date | 2017-09-26 |
| Date Added to Maude | 2018-03-22 |
| 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 | PHARMACIST |
| 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 | INJECTOR |
| Product Code | ONG |
| Date Received | 2018-03-22 |
| Catalog Number | 515003 |
| Lot Number | 1709101 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-22 |