BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20678860 · Received November 13, 2024

    Report

    Report Number
    1213809-2024-00835
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 18, 2024
    Report Date
    January 21, 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

    TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE AND PICTURES, THE STOPPER¿S ANGULARITY WAS OBSERVED DEFECTIVE. IT IS MOST LIKELY THAT THE STOPPER ANGULARITY DEFECT RESULTED FROM THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309628 AND LOT NUMBER 2202719. ALL VISUAL INSPECTIONS WERE PERFORMED, AND ONE (1) QUALITY NOTIFICATION (QN) WAS IDENTIFIED THAT COULD BE RELATED TO THIS REPORTED INCIDENT. WHEN THE QN WAS DETECTED, THE MANUFACTURING PROCESS WAS STOPPED, THE MACHINERY WAS REQUALIFIED, AND THE LINE WAS ENTIRELY CLEARED OF DEFECTS PRIOR TO RESUMING PRODUCTION. THE FINAL LOT WAS THEN INSPECTED AND ACCEPTED BASED ON THE CONTROL PLAN AND APPROVED FOR RELEASE. HOWEVER, IT IS POSSIBLE THAT A LIMITED NUMBER OF PIECES ESCAPED DETECTION WITH THIS CONDITION. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY 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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197908 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2202719 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown