BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 23953899 · Received January 4, 2026

    Report

    Report Number
    1213809-2025-00804
    Event Type
    Malfunction
    Date Received
    January 4, 2026
    Date of Event
    December 11, 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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. TEN SAMPLES AND ONE PHOTO OF 5 ML EUROGRAPHIC SYRINGES (PART NUMBER 309649, BATCH 5181790) WERE RECEIVED FOR EVALUATION. ALL SAMPLES ARRIVED IN SEALED PACKAGES WITH COMPLETE PRODUCT INFORMATION, AND NO DEFECTS WERE OBSERVED ON ANY OF THE SYRINGES. SILICONE WAS VISIBLE ON THE STOPPERS; HOWEVER, IT WAS NEITHER POOLING NOR STRINGING AND IS ACCEPTABLE PER PRODUCT SPECIFICATIONS. THE PHOTO SHOWED A LOOSE SYRINGE WITH THE SAME NORMAL SILICONE APPEARANCE. SILICONE IS AN INERT, NON TOXIC MEDICAL LUBRICANT ESSENTIAL TO SYRINGE FUNCTION AND DOES NOT POSE ANY SAFETY OR PERFORMANCE CONCERNS. IT HAS BEEN SAFELY USED IN THIS APPLICATION FOR MORE THAN 25 YEARS, WITH DISTRIBUTION EXCEEDING 30 BILLION UNITS AND NO KNOWN ADVERSE CLINICAL EFFECTS ASSOCIATED WITH UNINTENTIONAL SILICONE DELIVERY. PLEASE REFER TO THE ATTACHED SILICONE QUANTITY GUIDELINE FOR REFERENCE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309649, LOT 5181790. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WAS APPROVED FOR SHIPMENT, AND COMPLIES WITH APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED, WITH INFORMATION DOCUMENTED IN MONTHLY TREND REPORTS. OUR BUSINESS TEAM REGULARLY REVIEWS COLLECTED DATA TO IDENTIFY ANY 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 THE BD SYRINGE 5ML LL EURO 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SILICONE DROPLETS IN SYRINGE. AFTER THE PATIENT HAS RECEIVED HEAVY WATER IN THE EYE, A BUBBLE IS SEEN IN THE SYRINGE. IT IS NOT AIR BUT LOOKS LIKE SILICONE OIL. THE SYRINGE IS KEPT, AND A RANDOM IDENTICAL SYRINGE IS UNPACKED TOGETHER WITH CHIEF PHYSICIAN (B)(6); IA DROPLET IS CLEARLY VISIBLE ON THE BLACK MEMBRANE. DURING USE: THE INCIDENCE HAS CAUSED NO HARM TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570748 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5181790 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown