FDA Adverse Event
Malfunction
Summary report: N
VANISHPOINT
MDR report key: 12180148
·
Received July 16, 2021
Report
- Report Number
- 12180148
- Event Type
- Malfunction
- Date Received
- July 16, 2021
- Date of Event
- June 21, 2021
- Report Date
- July 12, 2021
- Manufacturer
- RETRACTABLE TECHNOLOGIES, INC.
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A NURSE ON EP 8-8 FOUND AN INSULIN SYRINGE THAT IS NOT DRAWING UP INSULIN. I HAVE THE SYRINGE AND LOT NUMBER (BELOW). WE TESTED MULTIPLE OTHER SYRINGES FROM THAT LOT, AND THEY WERE FUNCTIONAL. LOT# M210101.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080328 | VANISHPOINT | SYRINGE, ANTISTICK | MEG | RETRACTABLE TECHNOLOGIES, INC. | 15271 | M210101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |