BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19399143 · Received May 26, 2024

    Report

    Report Number
    1213809-2024-00315
    Event Type
    Malfunction
    Date Received
    May 26, 2024
    Date of Event
    May 6, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE AND ONE PHOTO OF A 3ML EUROGRAPHIC SYRINGE (P/N - 309658) BATCH 1024148 WERE RECEIVED AND EVALUATED. THE SAMPLE RECEIVED IN AN UNSEALED PACKAGE HAS THE STOPPER INSECURE TO THE PLUNGER ROD. THE PHOTO SHOWS ONE LOOSE SYRINGE WITH THE STOPPER INSECURE AS DESCRIBED ABOVE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER INSECURE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1024148 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "AN E-MAIL TO INFORM YOU OF A QUALITY DEFECT ON REFERENCE 309658 SERINGUE 3P 3ML LOT 1024148 EXPIRY DATE 31/12/2025. BLACK GASKET BADLY POSITIONED, CF PHOTO."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299848 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1024148 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown