FDA Adverse Event
Malfunction
Summary report: N
CAREPOINT SAFETY LUER LOCK SYRINGE
MDR report key: 11404264
·
Received March 2, 2021
Report
- Report Number
- MW5099743
- Event Type
- Malfunction
- Date Received
- March 2, 2021
- Report Date
- February 26, 2021
- Manufacturer
- ALLISON MEDICAL, INC
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
THE PLUNGER DOES NOT ATTACH TO THE RUBBER STOPPER WHICH CAUSES FAILURE OF WITHDRAWING LIQUID OUT OF THE VIAL. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299098 | CAREPOINT SAFETY LUER LOCK SYRINGE | SYRINGE, PISTON | FMF | ALLISON MEDICAL, INC | 3ML 25G X 1''.50MM X 25.4MM | 20200915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |