BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18504799 · Received January 12, 2024

    Report

    Report Number
    1213809-2023-01535
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    October 3, 2023
    Report Date
    March 4, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: THREE SAMPLES AND FOUR PHOTOS OF 1 ML LUER-LOK SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE SAMPLES AND PHOTOS FROM LOT NUMBER 1200757 REGARDING MATERIAL NUMBER 309628. ALL SAMPLES WERE RECEIVED LOOSE WITH ONE BARREL CUT AT THE 0.3ML GRADUATION LINE. ALL SAMPLES HAVE A LINE OF DRIED SILICONE LARGER THAN LEVEL 4 BETWEEN THE RIBS OF THE STOPPER. ALL FOUR IMAGES EACH SHOW ONE LOOSE STOPPER WITH THE CONDITION AS DESCRIBED ABOVE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF (B)(4) UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. SILICONE IS APPLIED AS A SPRAY OF PARTICLES TO THE INSIDE OF THE BARREL. IT IS UNCLEAR WHAT TYPE OF STORAGE AND HANDLING CONDITIONS THE PRODUCT WAS SUBJECTED TO AFTER LEAVING THE MANUFACTURING PLANT. IT IS POSSIBLE CERTAIN CONDITIONS OUTSIDE THE MANUFACTURING ENVIRONMENT CONTRIBUTED TO THE CONDITION OF SILICONE PARTICLES OBSERVED IN THE SAMPLE RECEIVED. THE CONDITION OBSERVED COULD NOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING PLANT, THEREFORE CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1200757 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 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 SYRINGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM DUTCH TO ENGLISH: "WE HAVE A COMPLAINT FOR ONE OF YOUR SYRINGES. A WHITE STRIPE NEXT TO THE THREAD WAS NOTICED BY THE CUSTOMER. A SAMPLE AND PICTURE ARE AVAILABLE. FOLLOWING LOT IS IN USE: 1200757."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701751 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1200757 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown