FDA Adverse Event
Other
Summary report: N
DUOPROSS 3 ML SYRINGE 22G 1" NEEDLE
MDR report key: 6144528
·
Received December 1, 2016
Report
- Report Number
- MW5066498
- Event Type
- Other
- Date Received
- December 1, 2016
- Manufacturer
- SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD.
- Product Code
- FMI
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE CUSTOMER CALLED TO NOTIFY THE PHARMACIST OF LEAKAGE FROM UNIT DOSE INTO THE SECURE SAFETY SHIELD. APPROX 1.5 MCI WERE NOT IN THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 790802 | DUOPROSS 3 ML SYRINGE 22G 1" NEEDLE | 3 ML SYRINGE WITH NEEDLE | FMI | SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD. | 20160106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |