BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23378240 · Received October 24, 2025

    Report

    Report Number
    1213809-2025-00674
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 31, 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
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 5097483 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    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

    T WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302995 BATCH # 5097483. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT INFORMATION PRODUCT CODE: 302995 PRODUCT DESCRIPTION: SYRINGE HYPO 10CC L/L BX/200 LOT/SERIAL #: (B)(6) EXPIRY DATE: N/A. PROBLEM INFORMATION PLEASE CITE CUSTOMER COMPLAINT # (B)(4) PLUNGER BENDS AND THE MEDICINE LEAKS OUT OF THE BOTTOM OF THE SYRINGE. DOCTOR ALSO HAD THE SAME ISSUE IN THE PEDIATRIC DAY UNIT. OCCURRENCES: 3 EACHES. SAMPLE INFORMATION INCIDENT SAMPLES: 0, REPRESENTATIVE SAMPLES: 0, NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504035 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5097483 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown