BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18842847 · Received March 5, 2024

    Report

    Report Number
    9614033-2024-00022
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 22, 2024
    Report Date
    May 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    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

    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

    NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON PREVIOUS INVESTIGATIONS FOR THIS BATCH NUMBER, FOREIGN MATTER IS CONFIRMED. IT IS POSSIBLE THE OIL CUSTOMER OBSERVED 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. MAINTENANCE PLAN FOR SILICONE INJECTION SYSTEM WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY IS WORKING WITH 20ML SYRINGE 303310 AND NOTICED OIL IN THE SYRINGE. WHAT IS THIS OIL AND IS IT SAFE? CALLER PROVIDED LOT NUMBER 3012142. CALLER STATES HIS FACILITY SENT THIS COMPLAINT TO BD PRODUCT COMPLAINTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669025 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3012142 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown