FDA Adverse Event
Malfunction
Summary report: N
SYRINGE 30ML LL BNS
MDR report key: 22903064
·
Received August 27, 2025
Report
- Report Number
- 1911916-2025-00617
- Event Type
- Malfunction
- Date Received
- August 27, 2025
- Date of Event
- August 11, 2025
- Report Date
- September 2, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 00382903010332
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF PR (B)(4) AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.
Additional Manufacturer Narrative · 0
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
NO ADDITIONAL INFORMATION.
Description of Event or Problem · 0
IT IS REPORTED CONDENSATION IN THE SYRINGES. EVENT DESCRIPTION: THIS IS TO REPORT DEFECTIVE PRODUCT ON ORDER PR3925427 FOR IN STOCK ITEM 301033 FOR IMPLICATED LOTS 4172676, 4212994, 5079444, 5062989, 5003386, 5043778, 5043967, AND 5003389 NOTED CONDENSATIONS IN THE SYRINGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1107782 | SYRINGE 30ML LL BNS | SYRINGE, PISTON | FMF | BECTON DICKINSON | 5043778 | 00382903010332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |