BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18352970 · Received December 18, 2023

    Report

    Report Number
    1213809-2023-01470
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 29, 2023
    Report Date
    June 17, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR ADDITIONAL INFORMATION/CORRECTION AND DEVICE EVALUATION. ADDITIONAL INFORMATION/CORRECTION: THE EVENT/PRODUCT PROBLEM WAS INCORRECT IN THE INITIAL MDR. CORRECT EVENT/PRODUCT PROBLEM IS LEAKAGE PAST STOPPER. ANNEX A CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX A CODE SHOULD BE A0504 - LEAK/SPLASH TWO PHOTOS OF 10ML LUER-LOK SYRINGES WERE RECEIVED. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS FROM BATCH #3152762 REGARDING ITEM #309605. BOTH PHOTOS SHOW ONE LOOSE SYRINGE FROM TWO DIFFERENT ANGLES, EACH WITH AN UNKNOWN BROWNISH-YELLOW FLUID FILLED TO THE 10ML GRADUATION LINE WITH FLUID BEHIND THE STOPPER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3152762 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.

    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

    TWO PHOTOS OF 10ML LUER-LOK SYRINGES (P/N - 309605) WERE RECEIVED AND EVALUATED. BOTH PHOTOS SHOW ONE LOOSE SYRINGE FROM TWO DIFFERENT ANGLES, EACH WITH AN UNKNOWN BROWNISH-YELLOW FLUID FILLED TO THE 10ML GRADUATION LINE WITH FLUID BEHIND THE STOPPER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING 100% VISUAL INSPECTION TODAY (LOT # 20231129-79DEC3) SEVERAL SYRINGES WERE FOUND WITH LIQUID UNDERNEATH THE STOPPER. UNITS ARE AVAILABLE FOR RETURN. THE SYRINGES CONTAIN MEDIA." (B)(6) 2023, (B)(6), STERILE SYRINGE TRAY 10ML #309605 / EXPIRY 5-31-2028, LOT # 3152762, LIQUID UNDER STOPPER - ABOUT 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053208 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152762 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown