MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BD LUER-LOK? DISPOSABLE SYRINGE WITH BD LUER-LOK? TIP 309657 manufactured by Becton Dickinson De Mexico.
| Report Number | 9614033-2020-00035 |
| MDR Report Key | 9856857 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2018-11-23 |
| Date Added to Maude | 2020-03-19 |
| 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 DE MEXICO |
| Manufacturer Street | AUTOPISTA 55 59 99 8400, K.M. 37.5 |
| Manufacturer City | CUAUTITLAN IZCALLI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD LUER-LOK? DISPOSABLE SYRINGE WITH BD LUER-LOK? TIP |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Model Number | 309657 |
| Catalog Number | 309657 |
| Lot Number | 8290711 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON DE MEXICO |
| Manufacturer Address | AUTOPISTA 55 59 99 8400, K.M. 37.5 CUAUTITLAN IZCALLI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |