BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24645903 · Received March 19, 2026

    Report

    Report Number
    3003152976-2026-00144
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 18, 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
    SZ
    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 THAT AN ORIGINALLY PACKAGED 50 ML BD SYRINGE WAS FOUND IN THE WAREHOUSE, WHICH WAS OBVIOUSLY HEAVILY CONTAMINATED. NO OTHER SUCH DEVICES WERE FOUND. THE SYRINGE CAN BE COLLECTED FROM THE CYTOSTATICS DEPARTMENT FOR INSPECTION BY CALLING (B)(6). IF IT HAD BEEN USED TO PREPARE STERILE DRUGS, PATIENTS COULD HAVE BEEN INFECTED. WHEN DID THE INCIDENT OCCUR? BEFORE USE SHORT DESCRIPTION SOILED SYRINGE IN STERILE PACKAGING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458135 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2510023 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown