BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 24738010 · Received March 31, 2026

    Report

    Report Number
    3003152976-2026-00155
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 23, 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
    AS
    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 50 ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICAL AREA REPORTS ¿ MULTIPLE FIBRES (PLASTIC) FOUND INSIDE WHAT IS SUPPOSED TO BE A STERILE SYRINGE/PLUNGER WHEN PACKAGE OPENED. NOTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479147 PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2505123 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1