BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21183152 · Received January 17, 2025

    Report

    Report Number
    1213809-2025-00011
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    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

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIALS: 309657 BATCH#: 3305235. IT WAS REPORTED THAT THE BD LUER-LOK HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT DURING ADMINISTRATION OF THE BLOOD PRODUCT, WRITER NOTICED SIGNIFICANT LEAKING FROM THE CONNECTION PORT OF THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WRITER USED A 3ML SYRINGE (LOT:3305235) AN 23G IM NEEDLE (LOT: 2101008) TO GIVE A DOSE OF HEPAGAM. DURING ADMINISTRATION OF THE BLOOD PRODUCT, WRITER NOTICED SIGNIFICANT LEAKING FROM THE CONNECTION PORT OF THE SYRINGE. SUPPLIER CATALOGUE NUMBER: 305886. SERIAL OR LOT NUMBER: (B)(6). MANUFACTURER CODE/MODEL: 309657.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056099 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3305235 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown