BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24393302 · Received February 19, 2026

    Report

    Report Number
    1213809-2026-00080
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 6, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903009121
    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

    (B)(4) - SUPPLEMENTAL MDR - SILICONE VISIBLE EIGHT SAMPLES OF 10 ML EUROGRAPHIC SYRINGES (PART NUMBER 300912) WERE RECEIVED AND EVALUATED, WITH TWO SAMPLES EACH FROM BATCHES 4347922, 5006307, 5163316, AND 5189108. ALL SAMPLES ARRIVED IN UNSEALED PACKAGING AND SHOWED NO DEFECTS. SILICONE WAS VISIBLE ON THE STOPPERS; HOWEVER, THERE WAS NO EVIDENCE OF STRINGING OR POOLING, INDICATING THAT THE AMOUNT WAS NOT EXCESSIVE AND MET PRODUCT SPECIFICATIONS. SILICONE IS AN INERT, NON TOXIC MEDICAL LUBRICANT THAT IS AN INTEGRAL COMPONENT OF DISPOSABLE SYRINGES, ENSURING PROPER PERFORMANCE IN CLINICAL USE. THIS CONDITION DOES NOT IMPACT PRODUCT SAFETY, EFFICACY, OR FUNCTIONALITY. SILICONE HAS BEEN USED IN THIS APPLICATION FOR OVER 25 YEARS, WITH MORE THAN 30 BILLION UNITS DISTRIBUTED AND NO KNOWN REPORTS OF ADVERSE CLINICAL EFFECTS RELATED TO UNINTENDED SILICONE DELIVERY. PLEASE REFER TO THE ATTACHED SILICONE QUANTITY GUIDELINE FOR ADDITIONAL DETAILS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT NUMBERS 4347922, 5006307, 5163316, AND 5189108. THE REVIEW IDENTIFIED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE 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 BD SYRINGE 10ML LL EUROGRAPHICS CONTAINED VISIBLE SILICONE. VERBATIM: LUBRICANT VISIBLE IN THE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176257 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5006307 00382903009121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other