BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18525616 · Received January 17, 2024

    Report

    Report Number
    9614033-2023-00151
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    INVESTIGATION SUMMARY: TWO SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITH WHAT APPEARS TO BE SILICONE. FOURIER TRANSFORM INFRARED SPECTROSCOPY WAS PERFORMED TO FURTHER ANALYZE. THE FOREIGN SUBSTANCES IS SILICONE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3012142 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RESULTS WERE REVIEWED FOR LOT 3012142 AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. QUANTIFICATION OF SILICONE PERFORMED ON THE SAMPLES WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID INSIDE OF THE SYRINGE, SAMPLES AVAILABLE AND NO PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063532 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3012142 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown