FDA Adverse Event
Malfunction
Summary report: N
CAREPOINT
MDR report key: 17121465
·
Received June 13, 2023
Report
- Report Number
- 1000138447-2023-00007
- Event Type
- Malfunction
- Date Received
- June 13, 2023
- Date of Event
- August 22, 2022
- Report Date
- June 13, 2023
- Manufacturer
- JUNG RIM MEDICAL INDUSTRIAL CO., LTD.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- GU, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
THE LUER CONNECTORS ARE NOT WORKING WITH NEEDLELESS ADAPTORS AND ARE DAMAGING SOME OF THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171762 | CAREPOINT | 3ML LUER LOCK SYRINGE | FMF | JUNG RIM MEDICAL INDUSTRIAL CO., LTD. | 13227-501-00 | 210602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |