BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24654708 · Received March 20, 2026

    Report

    Report Number
    3003152976-2026-00146
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 19, 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
    FR
    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: BLACK SPOT ON THE TUBE WHEN DID THE INCIDENT OCCUR? DURING USE IT WAS REPORTED THAT UPON OPENING THE SYRINGE: IT IS COVERED WITH BLACK SPOTS, EVEN ON THE SCREW-ON PART, WHICH SEEM TO COME OFF WHEN RUBBED DURING HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601985 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2510121 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown