BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21288935 · Received January 31, 2025

    Report

    Report Number
    1213809-2025-00061
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 17, 2025
    Report Date
    March 8, 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

    (B)(4). STOPPER JAMMED / INSECURE. ONE SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT SYRINGE HAS NOTICEABLY DAMAGED STOPPER. THE OBSERVED CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THE DAMAGED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2202719. A NOTIFICATION FOR THIS DEFECT WAS WRITTEN DURING THE PRODUCTION OF THIS BATCH. A REQUALIFICATION WAS PERFORMED, AND THE LINE WAS CLEARED OF DEFECTS. HOWEVER, IT IS POSSIBLE THAT A LIMITED NUMBER OF PIECES WERE ABLE TO ESCAPE DETECTION UNDER THIS CONDITION. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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

    IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS JAMMED / INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS NOT LEVEL (TILTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511175 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2202719 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown