BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23656145 · Received November 26, 2025

    Report

    Report Number
    9614033-2025-00115
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 27, 2025
    Report Date
    February 25, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE PHOTO AND TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON INSPECTION, IT WAS OBSERVED THAT THE STOPPER IS DEFORMED; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE POSSIBLE ROOT CAUSE COULD BE TRACED TO MANUFACTURING. DURING THE ASSEMBLY STAGE, THE COMPONENTS (PLUNGER WITH STOPPER AND BARREL) MAY NOT HAVE ALIGNED CORRECTLY, CAUSING THE ASSEMBLY TO BE FORCED AND RESULTING IN A DEFECT SIMILAR TO THE ONE REPORTED BY THE CUSTOMER. AN ACTION PLAN HAS BEEN PUT IN PLACE AS A RESULT OF THIS REPORT. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #303310 LOT #5105886 IT WAS REPORTED BY CUSTOMER THAT HAD BLACK PLUNGER ABNORMALITY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2025, ONE X BD 20 ML SYRINGE LUER-LOK TIP (REF 303310), (LOT 5105886, EXP 2030-04-30) HAD BLACK PLUNGER ABNORMALITY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292093 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5105886 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown