BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25028577 · Received April 29, 2026

    Report

    Report Number
    3003152976-2026-00198
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 16, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. APPLICABLE 510K NUMBERS ARE K182589; K980987, 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 50ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED, DARK DIRT (DARK SPOTS) ON THE INNER SURFACE OF THE SYRINGE. AFTER EMPTYING THE SYRINGE, DIRT REMAINED ON THE INNER SURFACE. THE INNER SURFACE WAS WIPED WITH A CLOTH AND THE DIRT REMAINED ON THE CLOTH. IN THE ATTACHED PICTURE, THE SYRINGE HAD ALREADY BEEN WIPED WITH A CLOTH AND THERE WERE SIGNIFICANTLY MORE DOTS AT FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184900 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2512094 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown