FDA Adverse Event
Malfunction
Summary report: N
1ML VANISH POINT II SYRINGE
MDR report key: 20708714
·
Received November 15, 2024
Report
- Report Number
- MW5162600
- Event Type
- Malfunction
- Date Received
- November 15, 2024
- Date of Event
- November 12, 2024
- Report Date
- November 13, 2024
- Manufacturer
- RETRACTABLE TECHNOLOGIES, INC.
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A 1ML VANISH POINT II SYRINGE DID NOT FULL DEPRESS AND DELIVER ENTIRE MEDICATION, AND NEEDLE DID NOT RETRACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2609311 | 1ML VANISH POINT II SYRINGE | SYRINGE, ANTISTICK | MEG | RETRACTABLE TECHNOLOGIES, INC. | 10131 | G240409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Male |