FDA Adverse Event
Malfunction
Summary report: N
BD LUER-LOK
MDR report key: 22991584
·
Received September 8, 2025
Report
- Report Number
- 22991584
- Event Type
- Malfunction
- Date Received
- September 8, 2025
- Date of Event
- July 20, 2025
- Report Date
- September 3, 2025
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PARTICLE WAS FOUND IN HEAT SEAL PORTION OF BD 50 ML SYRINGE. LOT NUMBER: 5092551, EXPIRATION: 03/31/2030. REF: 309653.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2067290 | BD LUER-LOK | SYRINGE, PISTON | FMF | BECTON, DICKINSON AND COMPANY | 309653 | 5092551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |