FDA Adverse Event
Other
Summary report: N
DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE
MDR report key: 6199059
·
Received December 20, 2016
Report
- Report Number
- MW5066860
- Event Type
- Other
- Date Received
- December 20, 2016
- Manufacturer
- SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD.
- Product Code
- FMI
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE NEEDLE POPPED OUT OF THE NEEDLE HUB WHEN THE NEEDLE PUNCTURED THE SEPTUM OF A VIAL. DATES OF USE: (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840652 | DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE | 3 ML SYRINGE WITH NEEDLE | FMI | SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD. | 20160602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |