BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 24392199 · Received February 19, 2026

    Report

    Report Number
    1213809-2026-00075
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 25, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. IT WAS REPORTED THAT A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. THE QUALITY TEAM HAS COMPLETED A AQL2, AND WE HAVE FOUND FURTHER LOTS WITH IMPACT. PART NUMBER, LOT NO; 309628, 5066461; 309628, 4354445; 309628, 4354445; 309628, 5101152; 309658, 5281022; 309658, 5072741; 309658, 4354445; 309658, 4352796; 309658, 4354445; 309658, 5072741.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425013 PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5281022 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other