BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 23888210 · Received December 24, 2025

    Report

    Report Number
    1213809-2025-00795
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 4, 2025
    Report Date
    March 3, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. FOUR SAMPLES OF 5 ML EUROGRAPHIC SYRINGES (PART NUMBER 309649) WERE RECEIVED IN UNSEALED PACKAGES AND EVALUATED, INCLUDING TWO SYRINGES FROM BATCH 4253037 AND ONE EACH FROM BATCHES 5072215 AND 5072216. ONE SYRINGE FROM BATCH 4253037 AND ONE FROM BATCH 5072215 SHOWED BROWN DISCOLORATION EMBEDDED IN THE BARREL, WHILE THE SECOND SYRINGE FROM BATCH 4253037 EXHIBITED MAJOR BARREL AND PLUNGER ROD DAMAGE. THE SYRINGE FROM BATCH 5072216 HAD SIGNIFICANT BARREL DAMAGE ACCOMPANIED BY BLACK FOREIGN MATTER IN A NON FLUID PATH AREA. ALL OBSERVED CONDITIONS WERE NON CONFORMING TO PRODUCT SPECIFICATIONS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC RESULTING FROM THE MOLDING PROCESS, WHERE RESIN CAN BE EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, PARTICULARLY DURING START UP; THIS EMBEDDED DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. THE BARREL DAMAGE, PLUNGER ROD DAMAGE, AND NON FLUID PATH FOREIGN MATTER ARE LIKELY ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309649, LOTS 4253037, 5072215, AND 5072216. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOTS MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WERE APPROVED FOR SHIPMENT, AND WERE FOUND TO BE IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED, WITH INFORMATION CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, IT WAS RECOGNIZED THAT BD SYRINGE 5ML LL CONTAINED FOREIGN MATTER. 1X BD LUER-LOK SYRINGE 5ML, LOT 5072215, REASON: CONTAMINATION IN THE PLASTIC AT THE BOTTOM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149493 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5072215 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other