BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24063089 · Received January 13, 2026

    Report

    Report Number
    1213809-2026-00004
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 24, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K110771
    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 - SYRINGE NEEDLE CONNECTIVITY ISSUE. SIXTEEN SAMPLES AND ONE PHOTOGRAPH OF 3 ML LUER LOK SYRINGES WITH 21 × 1" NEEDLES (PART NUMBER 309575) WERE EVALUATED. TWO SEALED SYRINGES WERE RECEIVED FROM BATCHES 5083505 AND 5241754; ONE HAD A STOPPER INSECURELY ATTACHED TO THE PLUNGER ROD, AND THE OTHER SHOWED DAMAGE TO THE PLUNGER ROD AND BARREL TIP, RESULTING IN A PARTIALLY ATTACHED NEEDLE. AMONG THE FOURTEEN LOOSE SYRINGES, TEN ARRIVED WITHOUT NEEDLES, EIGHT WITH NO DEFECTS AND TWO WITH BARREL DAMAGE, WHILE FOUR ARRIVED WITH NEEDLES ATTACHED, INCLUDING ONE ACCEPTABLE SAMPLE AND THREE WITH STOPPERS INSECURELY ATTACHED. IN ADDITION, EIGHT LOOSE NEEDLES WERE RECEIVED. THE PHOTOGRAPH PROVIDED ALIGNS WITH THE OBSERVED DEFECTS. THESE CONDITIONS DO NOT MEET PRODUCT SPECIFICATIONS. ALTHOUGH HUB REMOVAL FORCE TESTING AT THE TIME OF MANUFACTURE MET REQUIREMENTS, POST MANUFACTURING CONDITIONS ARE UNKNOWN; THEREFORE, USERS SHOULD ENSURE PROPER NEEDLE CONNECTION BY HAND TIGHTENING BEFORE USE. THE DAMAGED BARRELS, PLUNGER RODS, AND INSECURE STOPPERS ARE POTENTIALLY LINKED TO THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309575, LOTS 5083505 AND 5241754. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. BOTH LOTS MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WERE APPROVED FOR SHIPMENT, AND ARE IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THIS INFORMATION WILL BE INCLUDED IN TREND REPORTS AND MONITORED ON A MONTHLY BASIS. 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 3ML LL W/NDL 21X1 RB DEMONSTRATED CONNECTION ISSUES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM WRITING TO BRING TO YOUR ATTENTION AN ISSUE WITH THE 3 ML SYRINGES WE RECEIVED FOR THE LOT NUMBER MENTIONED IN THE ATTACHED FORM. WE HAVE IDENTIFIED NUMBER OF DEFECTIVE 3 ML SYRINGES WITHIN THE CASES RECEIVED. SPECIFICALLY, THE SYRINGE PLUNGER SEAL IS NOT PROPERLY INTACT ON SEVERAL UNITS FOUND IN THE BOXES. ADDITIONALLY, SOME OF THE SYRINGES WE FOUND WITH LOOSE NEEDLES IN THE PACK. FOR YOUR REFERENCE AND FURTHER REVIEW, I HAVE ATTACHED PHOTOS SHOWING EXAMPLES OF THE DEFECTIVE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161559 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5083505 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other