BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22149204 · Received June 5, 2025

    Report

    Report Number
    1213809-2025-00376
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 16, 2025
    Report Date
    August 5, 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
    IL, 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) - SUPPLEMENTAL MDR - SYRINGE NEEDLE CONNECTIVITY ISSUE. ONE SAMPLE AND TWO PHOTOS OF A 1ML LUER-LOK SYRINGE WERE RECEIVED AND EVALUATED. THE SAMPLE WAS RECEIVED LOOSE ALONG WITH AN EMPTY 'IZERVAY' BOX CARTON. UPON EVALUATION, NO DEFECTS WERE FOUND ON THE SYRINGE, AND A BD NEEDLE WAS ATTACHED WITH NO CONNECTIVITY ISSUES. ONE PHOTO SHOWS THE PRODUCT INFORMATION ON THE 'IZERVAY' BOX, AND THE OTHER SHOWS A LOOSE SYRINGE PLACED ON THE BOX; HOWEVER, THE REPORTED DEFECT IS NOT VISIBLE IN THE PHOTO. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATIONS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3041968. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309628, BATCH#: 3041968. RCC RECEIVED A COMPLAINT VIA EMAIL. WHEN EXPRESSING THE AIR FROM THE SYRINGE, AFTER DRAWING UP THE IZERVAY FROM THE VIAL, THE NEEDLE CAME OFF THE SYRINGE AND MEDICATION CAME OUT OF THE SYRINGE. PRODUCT NUMBER: 309628, LOT NUMBER: 3041968. UNABLE TO USE PRODUCT. MEDICATION WASTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762050 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3041968 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown