BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22484926 · Received July 11, 2025

    Report

    Report Number
    1213809-2025-00467
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER TWO PHOTOS OF 10ML LUER-LOK SYRINGES (PART NUMBER 302995) WERE REVIEWED. ONE IMAGE SHOWS SIX PACKAGES FROM THE TOP WEB SIDE, INCLUDING PRODUCT DETAILS, WITH THREE FROM BATCH 5121240, TWO FROM 5097487, AND ONE FROM 5051968. THE SECOND IMAGE DISPLAYS A LOOSE PLUNGER ROD WITH AN ATTACHED STOPPER THAT APPEARS WET, CONSISTENT WITH THE PRESENCE OF SILICONE. THE AMOUNT OF SILICONE IS NOT EXCESSIVE AND MEETS PRODUCT SPECIFICATIONS. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 25 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 30 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. PLEASE SEE ATTACHED SILICONE GUIDELINE. 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 THE BD SYRINGE 10ML LL S/C 200 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302995. LOT #5051968, 5121240, 5097487. SEVERAL 10ML SYRINGES APPEARED TO HAVE MOISTURE OR RESIDUE ON THE PLUNGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948115 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5121240 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown