BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23407970 · Received October 28, 2025

    Report

    Report Number
    1213809-2025-00678
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 30, 2025
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. BATCH 3038025 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. MATERIAL # 309628 IS A 1ML LL SYRINGE THAT IT IS SOLD WITH NO NEEDLE ASSEMBLY, ONLY THE SYRINGE. THE NEEDLE USED BY THE CUSTOMER IS UNKNOWN; THEREFORE, NO FURTHER INVESTIGATION IS TO BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309628 BATCH#: 3038025 IT WAS REPORTED BY THE CUSTOMER THAT MEDICATION LEAKED FROM NEEDLE ADDITIONAL INFORMATION PROVIDED: I APOLOGIZE FOR THE CONFUSION. A PHOTO IS CURRENTLY NOT AVAILABLE. I AM ACTIVELY TRYING TO REACH THE CUSTOMER TO VERIFY IF PHOTO OR A RETURN SAMPLE IS AVAILABLE. ATTACHED IS AN UPDATED BD GLOBAL PRODUCT COMPLAINT REPORT FORM FOR CN-013677 ¿ SYRINGE COMPONENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905636 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3038025 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown