BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24392246 · Received February 19, 2026

    Report

    Report Number
    1213809-2026-00074
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 11, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. IT WAS REPORTED THAT A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. THE QUALITY TEAM HAS COMPLETED A AQL2, AND WE HAVE FOUND FURTHER LOTS WITH IMPACT. PART NUMBER: LOT NO: 309628 , 5066461, 309628 , 4354445, 309628, 4354445, 309628 , 5101152, 309658 , 5281022, 309658 , 5072741, 309658, 4354445, 309658 , 4352796, 309658 , 4354445, 309658, 5072741.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455907 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4352796 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other