FDA Adverse Event
Malfunction
Summary report: N
BD SYRINGE
MDR report key: 24981763
·
Received April 24, 2026
Report
- Report Number
- 3003152976-2026-00193
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Date of Event
- April 6, 2026
- Report Date
- April 13, 2026
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
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 NS HAD TIP BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302055, BATCH#: 2501081. COMPLAINT VIA EMAIL. WE RECEIVED COMPLAINT: (B)(4), INDICATING A SYRINGE BROKE DURING USE BY THE CUSTOMER. THIS EVENT WAS EXPERIENCED WITH USE OF SYRINGE ITEM: 153238, LOT: 2501081. A PHOTO WAS PROVIDED; THE PHYSICAL SAMPLE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591243 | BD SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2501081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |