MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for BD?PHASEAL? INJECTOR LUER LOCK N35C 515004 manufactured by Becton Dickinson, S.a..
[94259385]
Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A device history review was not conducted because a lot number could not be determined. Conclusion: bd was unable to confirm the customer? S indicated failure mode because no samples or photos were received to confirm the stated defect.
Patient Sequence No: 1, Text Type: N, H10
[94259386]
It was reported there was a safety failure of the bd phaseal? Injector luer lock n35c. The needle of the product failed to be covered. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2017-00141 |
| MDR Report Key | 7077361 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-04 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-12-01 |
| 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 | 2017-12-01 |
| Catalog Number | 515004 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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 | 2017-12-01 |