FDA Adverse Event
Malfunction
Summary report: N
BD LUER-LOK
MDR report key: 24130098
·
Received January 21, 2026
Report
- Report Number
- 24130098
- Event Type
- Malfunction
- Date Received
- January 21, 2026
- Date of Event
- December 20, 2025
- Report Date
- December 29, 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
PARTICULATE FOUND IN THE GASKET OF 20ML BD LUER-LOK TIP SYRINGE. REF 303310, LOT 5163348, EXP 2030-06-30, SAMPLE SHIPPED TO VENDOR. MANUFACTURER RESPONSE FOR 20ML SYRINGE LUER-LOK TIP, BD 20ML SYRINGE LUER-LOK TIP (PER SITE REPORTER). EMAILED VENDOR REP ON [REDACTED], MAILED SAMPLE FOR INVESTIGATION [REDACTED].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192408 | BD LUER-LOK | SYRINGE, PISTON | FMF | BECTON, DICKINSON AND COMPANY | 303310 | 5163348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |