BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK PRECISIONGLIDE

    MDR report key: 23816479 · Received December 16, 2025

    Report

    Report Number
    1213809-2025-00784
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 26, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096428
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THAT THE SYRINGE EXHIBITED A BLACK LIQUID SUBSTANCE ON THE TOP PORTION. BECAUSE NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM REVIEWED THREE PHOTOGRAPHS OF A 10ML LUER LOK SYRINGE. ONE PHOTOGRAPH SHOWS THE VARIABLE DATA ON THE TOP WEB SLIP, INCLUDING ALL APPLICABLE PRODUCT INFORMATION. THE SECOND SHOWS THE CLEAR SIDE OF THE PACKAGE WITH THE NEEDLE SHIELD DISPLAYING DARK DISCOLORATION. THE THIRD SHOWS THE SYRINGE OUTSIDE THE PACKAGE WITH THE SAME DISCOLORATION VISIBLE ON THE NEEDLE SHIELD. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED IN THE IMAGES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309642, LOT 5232394. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED PER REQUIREMENTS, WITH NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED IN ACCORDANCE WITH THE INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH LOT OF NEEDLES USED IN MANUFACTURING THIS FINAL BATCH, AND NO DOCUMENTATION OF THIS TYPE OF DEFECT WAS FOUND DURING THE PRODUCTION RUN. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE PHOTOGRAPH BASED ASSESSMENT, THE CUSTOMERS REPORTED SYMPTOM IS CONFIRMED. IN THE ABSENCE OF THE PHYSICAL SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    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 THE BD SYRINGE 10ML LL W/NDL 21X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309642 BATCH#: 5232394. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER XXX REPORTED RECEIVING ITEM# BF309642 WITH BLACK LIQUID/SUBSTANCE ON THE TOP PART. PLEASE SEE ATTACHED. WAITING FOR CUSTOMER ADDITIONAL INFORMATION. - PURCHASE ORDER NUMBER - QUANTITY PURCHASED - QUANTITY AFFECTED WOULD LIKE TO REPORT THAT ITEM BF309642 HAS A BLACK SUBSTANCE IN THE NEEDLE AREA. (CUSTOMER EMAIL COPY ATTACHED WITH PICTURES)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943395 BD LUER-LOK PRECISIONGLIDE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5232394 00382903096428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown