FDA Adverse Event
Injury
Summary report: N
VANISHPOINT INSULIN SYRINGE U-100
MDR report key: 5646264
·
Received May 7, 2016
Report
- Report Number
- MW5062186
- Event Type
- Injury
- Date Received
- May 7, 2016
- Date of Event
- May 7, 2016
- Report Date
- May 7, 2016
- Manufacturer
- RETRACTABLE TECHNOLOGIES, INC.
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INSULIN SYRINGE RETRACTABLE POINT DID NOT FUNCTION. THE SYRINGE WE USE HAD MALFUNCTIONED SEVERAL TIMES FOR ME (THIS IS AT LEAST THE THIRD TIME) SINCE WE HAVE STARTED USING THEM. VANISHPOINT INSULIN SYRINGE NAFDAC #03-0623, REF (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294417 | VANISHPOINT INSULIN SYRINGE U-100 | VANISHPOINT INSULIN SYRINGE | MEG | RETRACTABLE TECHNOLOGIES, INC. | U-100 | 15221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |