FDA Adverse Event
Malfunction
Summary report: N
VANISHPOINT SYRINGE
MDR report key: 11627793
·
Received April 6, 2021
Report
- Report Number
- MW5100577
- Event Type
- Malfunction
- Date Received
- April 6, 2021
- Date of Event
- March 12, 2021
- Report Date
- March 22, 2021
- Manufacturer
- RETRACTABLE TECHNOLOGIES, INC.
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
VANISH POINT SYRINGE; SUPPLIED UNDER EMERGENCY USE AUTHORIZATION (EUA): INCLUDED IN THE PFIZER COVID VACCINE KITS. DEFECTIVE BENT NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522964 | VANISHPOINT SYRINGE | SYRINGE, ANTISTICK | MEG | RETRACTABLE TECHNOLOGIES, INC. | G201007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |