BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21032722 · Received December 29, 2024

    Report

    Report Number
    1213809-2024-01007
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    December 5, 2024
    Report Date
    February 20, 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
    KS
    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

    SEVEN SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED. FIVE SAMPLES HAD DAMAGED STOPPERS, SEVERELY IMPACTING THEIR ANGULARITY. THE CONDITION OBSERVED IS NON-CONFORMING WITH PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THE DAMAGED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE STOPPER ANGULARITY DEFECT WAS APPROPRIATELY DETECTED DURING THE BATCH MANUFACTURING PROCESS. THE PROCESS WAS STOPPED, THE MACHINE WAS REQUALIFIED, AND THE LINE WAS ENTIRELY CLEARED OF DEFECTS PRIOR TO RESUMING PRODUCTION. HOWEVER, IT IS POSSIBLE THAT A LIMITED NUMBER OF PIECES ESCAPED DETECTION UNDER THIS CONDITION. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2202719. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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 DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM KOREAN TO ENGLISH: THE RUBBER PART AT THE END OF THE PLUNGER IS CROOKED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433476 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2202719 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown