BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 23927238 · Received December 30, 2025

    Report

    Report Number
    1213809-2025-00799
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 28, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER: ONE SAMPLE OF A 1 ML LUER LOK SYRINGE (PART NUMBER 309628, BATCH 5190556) WAS RECEIVED IN ITS SEALED PACKAGE WITH COMPLETE PRODUCT INFORMATION. EVALUATION SHOWED BROWN DISCOLORATION ON THE BARREL CONSISTENT WITH A BURNT BARREL, WHICH IS NON-CONFORMING TO PRODUCT SPECIFICATIONS. THE EMBEDDED FOREIGN MATERIAL APPEARS TO BE DEGRADED PLASTIC, LIKELY CAUSED BY RESIN BEING EXPOSED TO PROLONGED HIGH TEMPERATURES IN THE MOLDING MACHINE DURING START UP. ACCORDING TO PROCEDURE, MOLDED PARTS PRODUCED AT START UP ARE TO BE SCRAPPED UNTIL NO DEGRADED MATERIAL IS OBSERVED; IF THIS STEP IS NOT PERFORMED THOROUGHLY, AN AFFECTED UNIT MAY PASS THROUGH. THIS CONDITION IS COSMETIC ONLY AND DOES NOT POSE A RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309628, LOT 5190556, CONFIRMED THAT ALL REQUIRED IN PROCESS AND FINAL INSPECTIONS WERE COMPLETED WITH NO RELATED QUALITY NOTIFICATIONS IDENTIFIED. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WAS APPROVED FOR SHIPMENT, AND COMPLIED WITH ALL APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 WAS PROVIDED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. VERBATIM: "BROWN SMEAR INSIDE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328256 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5190556 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other