FDA Adverse Event
Injury
Summary report: N
VANISHPOINT SYRINGE 1ML / VANISH POINT RETRACTABLE SYRINGE
MDR report key: 11628191
·
Received April 6, 2021
Report
- Report Number
- MW5100592
- Event Type
- Injury
- Date Received
- April 6, 2021
- Date of Event
- April 2, 2021
- Report Date
- April 2, 2021
- Manufacturer
- RETRACTABLE TECHNOLOGIES, INC.
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
AT THE (B)(6) COVID CLINIC, A NURSE VOLUNTEER REPORTED TO ME THAT THE NEEDLE WAS STUCK IN THE PATIENT'S ARM UPON RECEIPT OF THE PFIZER VACCINE. THE PATIENT WAS SENT TO (B)(6) MEDICAL CENTER ED AND HAD AN X-RAY THAT CONFIRMED THAT THE NEEDLE WAS STUCK. THE ED TEAM WAS UNABLE TO GET THE NEEDLE OUT, AND REFERRED THE PATIENT TO A SPECIALIST. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522979 | VANISHPOINT SYRINGE 1ML / VANISH POINT RETRACTABLE SYRINGE | SYRINGE, ANTISTICK | MEG | RETRACTABLE TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |