FDA Adverse Event
Malfunction
Summary report: N
LUER-LOK
MDR report key: 24297522
·
Received February 9, 2026
Report
- Report Number
- 9610847-2026-00051
- Event Type
- Malfunction
- Date Received
- February 9, 2026
- Date of Event
- January 22, 2026
- Report Date
- May 5, 2026
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FMF
- UDI-DI
- 00382903056170
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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 BY CUSTOMER THAT BATCHING SYRINGES LEAKING DRUG AT THE PLUNGER AREA OF THE SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: (B)(6) 2026 COMPLAINT NUMBER: (B)(4) ACCOUNT NUMBER: (B)(4) ITEM NUMBER: 308-305617 ,LOT# 5129980, EXPIRY 2030-04-30 LOT# 5195506 , EXPIRY 2030-06-30 SAMPLE AVAILABLE: YES ITEM DESCRIPTION: 20ML LUER-LOK TIP STERILE SYRINGE PACK INCIDENT DESCRIPTION: AS PER ACCOUNT, BATCHING SYRINGES LEAKING DRUG AT THE PLUNGER AREA OF THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46356 | LUER-LOK | SYRINGE | FMF | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 5195506 | 00382903056170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |