FDA Adverse Event
Malfunction
Summary report: N
BD LUER-LOK
MDR report key: 24847637
·
Received April 11, 2026
Report
- Report Number
- 1213809-2026-00191
- Event Type
- Malfunction
- Date Received
- April 11, 2026
- Date of Event
- March 24, 2026
- Report Date
- May 6, 2026
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903096282
- PMA / PMN Number
- K941562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
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
IT WAS REPORTED THAT BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. VERBATIM: IV PHARMACIST DISCOVERED AN ISSUE WITH BD ITEM # 309628. THERE WAS A THIN LAYER OF FLUID/OIL ON THE INSIDE OF THE BARREL. WHEN THE PLUNGER IS PULLED BACK, A SMALL AMOUNT OF THIS FLUID COLLECTS JUST UNDER THE PLUNGER. WHEN THEY REMOVED THE PLUNGER AND RUBBED IT ON THEIR FINGER, THERE WAS TRANSPARENT FLUID ON THEIR FINGER. THEY HAVE PULLED BACK THE 2 LOTS THAT THEY KNOW TO BE AFFECTED. THE LOTS ARE: 6022248 AND 5149605. THERE ARE 2 LOTS NOT AFFECTED THAT THEY ARE UTILIZING IN THE PHARMACY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166829 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 5149605 | 00382903096282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |