BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23798706 · Received December 13, 2025

    Report

    Report Number
    1213809-2025-00773
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 26, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A LOOSE SYRINGE SAMPLE AND TWO PHOTOS WERE PROVIDED FOR INVESTIGATION, ALONG WITH AN EMPTY IZERVAY CARTON. VISUAL EVALUATION OF THE SYRINGE FOUND NO DEFECTS, AND THE ATTACHED BD NEEDLE SHOWED NO CONNECTIVITY ISSUES. LEAK TESTING CONFIRMED THE SYRINGE TO NEEDLE CONNECTION WAS SECURE. THE PROVIDED PHOTOS SHOWED THE CARTONS PRODUCT INFORMATION AND A LOOSE SYRINGE WITH AN UNKNOWN YELLOW NEEDLE AND AN UNIDENTIFIED NEEDLE CANNULA INSIDE AN UNKNOWN VIAL, HOWEVER, THE REPORTED DEFECT COULD NOT BE VERIFIED FROM EITHER THE SAMPLE OR THE IMAGES, AND THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309628, LOT NUMBERS 4256624 AND 3041968, CONFIRMED THAT ALL REQUIRED IN PROCESS AND FINAL INSPECTIONS WERE COMPLETED WITH NO RELATED QUALITY NOTIFICATIONS, AND BOTH LOTS MET ACCEPTANCE CRITERIA AND WERE APPROVED FOR SHIPMENT.

    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

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309628. BATCH # 4256624, 3041968. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE CAME OFF FROM SYRINGE CAUSED LEAK OF MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE CAME OFF FROM SYRINGE CAUSED LEAK OF MEDICATION. (IN DETAIL. "THE MEDICATION WAS ALREADY OUT OF THE VIAL AND INTO THE SYRINGE BUT WHEN IT WAS BEING SUPPRESSED TO GATHER THE MEDICATION TOGETHER IN THE SYRINGE THE NEEDLE CAME OFF AT THAT TIME WITH MEDICATION LEAVING THE SYRINGE AS WELL. DURING THIS TIME OF PUTTING THE NEEDLE BACK ON THE TIP OF THE SYRINGE WAS TOUCHED MAKING IT NON-STERILE".) PRODUCT#:305200, 309628. "THE DOCTOR FELT THIS BECAME UNSTERILE AND UNSAFE TO ADMINISTER TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039985 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3041968 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown