BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 25174846 · Received May 14, 2026

    Report

    Report Number
    1213809-2026-00252
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE SEE ATTACHED SYRINGE 10ML HAS A BLACK MARKING. LOT 5232581. HAS BEEN OPENED BUT NOT USED. CAN SEND BACK FOR REVIEW / INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415433 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5232581 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1