FDA Adverse Event
Malfunction
Summary report: N
BD SYRINGE 20ML LL BNS
MDR report key: 23408500
·
Received October 28, 2025
Report
- Report Number
- 1911916-2025-00703
- Event Type
- Malfunction
- Date Received
- October 28, 2025
- Date of Event
- August 27, 2025
- Report Date
- October 13, 2025
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H3: 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 20 ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #301031; LOT #5090296. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER REPORTED HAVING SEVERAL QUALITY ISSUES IN LAMI PACKS. FOR 20CC SYRINGE AS THE DEBRIS IS LOCATED ON THE INSIDE OF SYRINGE. MFG. SKU NUMBER: 301031. LOT #: 5090296.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1679098 | BD SYRINGE 20ML LL BNS | PISTON SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 5090296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |