BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 21905831 · Received April 24, 2025

    Report

    Report Number
    1213809-2025-00304
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    January 15, 2025
    Report Date
    June 23, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 REPORT FOR CORRECTION. THE POSSIBLE LOT NUMBER PROVIDED IS COVERED UNDER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309628 BATCH # 3122722. RCC RECEIVED A COMPLAINT VIA EMAIL. ON 15JAN2025 XXX WAS INFORMED OF AN EVENT WITH XXX 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM- SYRINGE. ON 27JAN2025, ONE SYRINGE RETURNED WITH GREEN PARTICLE OBSERVED IN PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. 1 ML SYRINGE CATALOG: 309628 LOT: 3122722. CUSTOMER RESPONSE ON (B)(6) 2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 15JAN2025. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A. 3. COULD YOU PLEASE CONFIRM IF THERE ARE ANY SAMPLES AVAILABLE TO SEND TO BD FOR INVESTIGATION? SAMPLE WILL NOT BE FORWARDED AT THIS TIME.

    Description of Event or Problem · 0

    THE POSSIBLE LOT NUMBER PROVIDED IS COVERED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275576 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown