BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24367796 · Received February 17, 2026

    Report

    Report Number
    1213809-2026-00071
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 9, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION BLACK BLEMISHES OR SPOTS WERE REPORTED AS VISIBLE ON OR WITHIN SYRINGES. TO SUPPORT THE INVESTIGATION, OUR QUALITY TEAM RECEIVED ONE HUNDRED 1ML LUER LOK SYRINGES, FULLY ASSEMBLED AND PROPERLY PACKAGED, FROM LOT 4354445 FOR EVALUATION. A QUALIFIED QUALITY REPRESENTATIVE PERFORMED A COMPREHENSIVE INSPECTION OF ALL UNITS AND FOUND THAT THREE OF THE ONE HUNDRED SYRINGES CONTAINED A LOOSE, WHITE, FIBER LIKE MATERIAL LOCATED OUTSIDE THE FLUID PATH. IN ADDITION, A STRING LIKE MATERIAL ASSOCIATED WITH THE COLLAR, ALSO LOCATED OUTSIDE THE FLUID PATH, WAS OBSERVED. THESE FINDINGS ARE NONCONFORMING TO PRODUCT SPECIFICATIONS AND ARE ATTRIBUTABLE TO THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309628, LOT 4354445. THE REVIEW CONFIRMED THAT ALL REQUIRED VISUAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT WAS INSPECTED AND ACCEPTED PER THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND IS CONSIDERED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE PRESENCE OF FOREIGN MATTER AS REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    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 BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. PLEASE SEE ATTACHED PICTURE EVIDENCE. 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 (B)(6) 2026. FCS WERE INFORMED ON THE 26TH JANUARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375982 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4354445 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other