BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML S/T BNS

    MDR report key: 19487980 · Received June 7, 2024

    Report

    Report Number
    1213809-2024-00346
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 23, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    CORRECTION: F CODE UPDATED TO NO PATIENT INVOLVEMENT. INVESTIGATION RESULTS: THREE SAMPLES AND TWO PHOTOS OF A 10 ML LL SYRINGE WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES AND PHOTOS FROM BATCH 3130001 REGARDING ITEM 301030. ALL SAMPLES WERE RECEIVED LOOSE. ONE PRESENTED A SIGNIFICANT AMOUNT OF WHITE DUST-LIKE FOREIGN MATTER INSIDE AND OUTSIDE THE FLUID PATH, WHILE THE REMAINING TWO SHOWED MULTIPLE WHITE PARTICULATES INSIDE THE FLUID PATH; NO INK DEFECTS WERE OBSERVED IN ANY OF THE PHYSICAL SAMPLES. ADDITIONALLY, TWO PHOTOS WERE EVALUATED; THE FIRST SHOWS TWO LOOSE SYRINGES, ONE WITH NO OBSERVABLE DEFECTS AND ANOTHER WITH A SIGNIFICANTLY BIG BLACK MASS THAT LOOKS TO BE OUTSIDE THE FLUID PATH AND APPEARS TO BE AN INK SMEAR. HOWEVER, IT CANNOT BE CONFIRMED BASED ON THE PHOTO. THE SECOND PHOTO SHOWS TWO LOOSE SYRINGES AS WELL. ONE HAS NO NOTICEABLE DEFECTS, WHILE THE OTHER APPEARS TO HAVE WHITE PARTICULATES INSIDE OR OUTSIDE THE FLUID PATH, WHICH CANNOT BE DETERMINED FROM THE PHOTO. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. AN FTIR ANALYSIS WAS PERFORMED, AND TWO MANUFACTURING TECHNICIANS AND ONE PROCESS ENGINEER WERE INTERVIEWED FOR THIS INVESTIGATION. THE RESULTS INDICATE THE WHITE FOREIGN MATTER IS MOST LIKELY DRIED SILICONE. 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 ATTACHMENT OF SILICONE TO THE BARREL WALLS AS OBSERVED IN THE PHOTOS. THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER IN THE FLUID PATH AND THE FOREIGN MATTER OUTSIDE THE FLUID PATH DEFECTS ARE 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 3130001 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML S/T BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: DURING THE FINAL STAGES OF PRODUCTION OF OUR MEDICAL DEVICES (BLISTER PACKAGING), A PRODUCTION OPERATOR NOTICED THAT THE SYRINGES INCORPORATED IN OUR KIT WERE VERY DIRTY. SOME SYRINGES APPEARED TO CONTAIN INK (FIGURE 1), WHILE OTHERS CONTAINED WHITE PARTICLES (FIGURE 2). FOLLOWING THIS OBSERVATION, 31 PARTS WERE BLOCKED AND DECLARED NONCONFORMING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031479 BD SYRINGE 10ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3130001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown