BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25144516 · Received May 11, 2026

    Report

    Report Number
    3003152976-2026-00223
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 11, 2026
    Report Date
    May 26, 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: THE FOLLOWING WAS REPORTED: PLEASE FIND ATTACHED A MEDICAL DEVICE VIGILANCE REPORT FROM THE (B)(6) HOSPITAL. WE KINDLY REQUEST THAT YOU FORWARD TO US THE INVESTIGATION REPORT¿SHOULD ONE BE REQUESTED BY THE ANSM¿OR YOUR CONCLUSIONS REGARDING THIS INCIDENT. THE DEVICE IN QUESTION IS AVAILABLE FOR YOUR INSPECTION AT OUR UNIT. IF YOU WISH TO ANALYZE IT, YOU MAY SEND US SUITABLE PACKAGING FOR ITS RETURN TO THE FOLLOWING ADDRESS: REFERENCE: (B)(4). LOT: 2601107. IT WAS REPORTED THAT ON (B)(6) 2026 PRESENCE OF PLASTIC PIECES DETACHING FROM THE LUERS OF 50 ML SYRINGES USED FOR EPS AND PCA. ACTIONS UNDERTAKEN IN THE PLANT: DEVICE NOT RETAINED. PHOTOS AVAILABLE. A NEW UNIT WAS RETAINED. PLASTIC DEBRIS APPEARS TO BE PRESENT AT INSIDE THE PACKAGE, MORE OR LESS ATTACHED TO THE BARREL. RISK OF VENOUS EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349970 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2601107 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1