BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24178881 · Received January 26, 2026

    Report

    Report Number
    9610847-2026-00030
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 20, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056187
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS AND 1 PHYSICAL SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE DEFECT REPORTED BY THE CUSTOMER WAS OBSERVED. BD DETERMINED THAT THE CAUSE OF THE FAILURE COULD BE EMBEDDED DEGRADED RESIN FROM THE MOLDING PROCESS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT THE SYRINGE WITH WAX TYPE MATERIAL ON THE PLUNGER AND BLACK INK MARKS ON THE TIP OF THE SYRINGE AS WELL. VERBATIM: I AM OFFICIALLY FILING ANOTHER COMPLAINT FOR 30 CC SYRINGE WITH WAX TYPE MATERIAL ON THE PLUNGER AND BLACK INK MARKS ON THE TIP OF THE SYRINGE AS WELL. THIS TIME THE LOT NUMBER IS DIFFERENT THAN PREVIOUSLY SUBMITTED COMPLAINT LOT 5112150. WE HAVE DISCARDED THAT LOT 5112150. THIS SYRINGE WAS NOT USED AND CAUGHT BEFORE FILLING. PLEASE SEE INFORMATION BELOW: ITEM: 30 CC SYRINGE TRAY (BD) QTY: (B)(4) LOT NUMBER: 5183734 MATERIAL ITEM CODE: 305618 SAMPLE IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254613 LUER-LOK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5183734 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown