MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-24 for BD ULTRA FINE? PEN NEEDLES 2865 320122 manufactured by Becton, Dickinson And Co..
Report Number | 9616657-2020-00048 |
MDR Report Key | 9876032 |
Report Source | CONSUMER,OTHER |
Date Received | 2020-03-24 |
Date of Report | 2020-04-01 |
Date of Event | 2020-03-04 |
Date Mfgr Received | 2020-03-04 |
Device Manufacturer Date | 2019-09-27 |
Date Added to Maude | 2020-03-24 |
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 AND CO. |
Manufacturer Street | DONORE ROAD |
Manufacturer City | DROGHEDA |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BD ULTRA FINE? PEN NEEDLES |
Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
Product Code | FMI |
Date Received | 2020-03-24 |
Model Number | 2865 |
Catalog Number | 320122 |
Lot Number | 9205404 |
Operator | LAY USER/PATIENT |
Device Availability | * |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BECTON, DICKINSON AND CO. |
Manufacturer Address | DONORE ROAD DROGHEDA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-24 |