FDA Adverse Event
Malfunction
Summary report: N
BD SYRINGE 20ML LL 120/PKG
MDR report key: 24423386
·
Received February 23, 2026
Report
- Report Number
- 3003152976-2026-00087
- Event Type
- Malfunction
- Date Received
- February 23, 2026
- Date of Event
- February 10, 2026
- Report Date
- February 13, 2026
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- UDI-DI
- 00382903006298
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BD SYRINGE 20ML LL 120/PKG HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING QUALITY CHECKS, MULTIPLE PLASTIPAK SYRINGES WERE IDENTIFIED WITH PARTICLES, FIBERS OR BLACK DOTS INSIDE THE PACKAGING AND SYRINGE. NAME: PLASTIPAK 20ML HYPODERMIC SYRINGE 3 PIECES CONCENTRIC LUER LOCK PO: (B)(4) LOT: 2507060 EXPIRY: 30/06/2030 QUANTITY REJECTED: (B)(4) PIECES 20ML ¿ PARTICLES INSIDE PACKAGING AND INSIDE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165461 | BD SYRINGE 20ML LL 120/PKG | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2507060 | 00382903006298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |