BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 24367798 · Received February 17, 2026

    Report

    Report Number
    1213809-2026-00069
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 10, 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: TWO PHOTOS WERE RECEIVED SHOWING THREE LOOSE, FULLY ASSEMBLED 3 ML LL SYRINGES PART NUMBER 309658 WITH PRINTING DEFECTS. IN THE FIRST PHOTO, ONE SYRINGE IS PARTIALLY MISSING THE BD LOGO AND TWO INK DOTS ON THE BARREL. THE SECOND PHOTO SHOWS THREE SYRINGES WITH ONE OR MORE UNINTENDED INK DOTS IN THE NON-SCALE MARKING AREA. THESE CONDITIONS ARE NON-CONFORMING TO PRODUCT SPECIFICATIONS, AND THE MISSING PRINT AND INK DOT DEFECTS ARE LIKELY ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309658, LOTS 4352796 AND 5072741. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOTS MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WERE APPROVED FOR SHIPMENT, AND ARE IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. CONFIRMED PRODUCTS AND LOT NUMBERS SO FAR THAT ARE CONFIRMED ARE BELOW: BD 1ML SYRINGES: LOT: 4354445 EXPIRY: 2029-11-30. BD 3ML SYRINGES: LOT: 4352796 EXPIRY: 2029-11-30. BD 3ML SYRINGES: LOT: 5072741 EXPIRY: 2030-02-28. OUT CLIENT NOTED THE BLEMISHES/ BLACK SPOTS ON THE 9TH JANUARY 2026. FCS WERE INFORMED ON THE 26TH JANUARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375983 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4352796 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other