BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 10CC LL W/SILICONE NO BD LOGO BNS

    MDR report key: 10347562 · Received July 30, 2020

    Report

    Report Number
    1213809-2020-00495
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY TEN LOOSE 10ML ASSEMBLED SYRINGE WERE RECEIVED. THE 10ML BARREL PRODUCT WAS OBSERVED TO HAVE BEEN ASSEMBLED BY THE CUSTOMER PRIOR TO RETURNING FOR EVALUATION. THE SAMPLES WERE VISUALLY EVALUATED. MOST SAMPLES WERE OBSERVED TO HAVE WHITE-LOOKING PARTICLES LEVEL 2 IN SIZE AND SMALLER ON THE STOPPER OR BARREL ROOF IN THE FLUID PATH. AT LEAST TWO SAMPLES WERE FOUND TO HAVE PARTICLES LARGER THAN LEVEL 2, WHICH WOULD BE REJECTABLE PER PRODUCT SPECIFICATION. PARTICLES HAD THE APPEARANCE OF PLASTIC BUT COULD NOT BE DEFINITIVELY IDENTIFIED WITHOUT FURTHER TESTING. THREE OF THE SAMPLES¿ BARRELS WERE OBSERVED TO HAVE SMALL AMOUNT OF DAMAGE, SUCH AS KNICKS, ON THE INSIDE OF THE FLANGE. HOWEVER, THE OTHER SAMPLES DID NOT HAVE ANY SIGNS OF DAMAGE. TWO SAMPLES WITH LEVEL PARTICLES LARGER THAN LEVEL 2 WERE SUBMITTED FOR FTIR ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYPROPYLENE MIXED WITH SILICONE. IN ADDITION, CURRENT PROCESS WAS INVESTIGATED FOR POTENTIAL FAILURE INCLUDING PRODUCT DAMAGE THAT COULD CREATE PARTICLES IN THE FLUID PATH. NO ISSUES WERE FOUND AT THE POINTS OF CONTACT IN THE ASSEMBLY MACHINE. TEST RUNS WERE PERFORMED TO VERIFY CURRENT PRODUCTION SETUPS ON BOTH ASSEMBLY MACHINES USED TO PACKAGE THIS PRODUCT. NO SETUP ISSUES WERE FOUND. AN 800 PIECE INSPECTION WAS PERFORMED PER ANSI Z1.4 LEVEL II NORMAL ON SEQUENTIAL CURRENT PRODUCTION SAMPLES ON THIS MACHINE. SAMPLES INCLUDED BOTH ASSEMBLY MACHINES. NO FOREIGN MATTER WAS FOUND IN THE FLUID PATH OF THE SAMPLES. BASED ON THE EVALUATION OF THE RETURNED SAMPLES AND INVESTIGATION OF THE CURRENT MANUFACTURING PROCESS, INCLUDING CURRENT PROCESS CAPABILITIES AND POTENTIAL ROOT CAUSES, THE REPORTED DEFECT COULD NOT BE CONFIRMED TO BE ORIGINATING AT THE MANUFACTURING PROCESS. TO CONTINUE ANY INVESTIGATIVE ACTIVITIES, SAMPLES THAT HAVE NOT BEEN ASSEMBLED BY CUSTOMER AND HAVE NOT BEEN MANIPULATED, WITH CONFIRMED DEFECT WOULD NEED TO BE SUBMITTED FOR EVALUATION. AT THIS POINT AND BASED ON THE INFORMATION AVAILABLE TODAY, INVESTIGATION IS CONCLUDED, AND NO FOREIGN MATTER IS CONFIRMED TO BE GETTING IN THE FLUID PATH ON THIS MACHINE. THIS MACHINE HAD PERMANENT ADJUSTMENTS PERFORMED TO REDUCE PLASTIC FM CONTAMINATION IN EARLY 2019. IN ADDITIONAL, STATIC FM CLEANING EQUIPMENT WAS INSTALLED IN LATE 2019/2020 AS FURTHER PROCESS IMPROVEMENTS TO REDUCE POTENTIAL PARTICULATE PRESENCE. SINCE THE DEFECTS IN THIS COMPLAINT COULD NOT BE CONFIRMED TO BE ORIGINATING AT THIS TIME AND ALL PROCESSES WERE CONFIRMED TO BE FUNCTIONING AS INTENDED, NO ADDITIONAL ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BARREL 10CC LL W/SILICONE NO BD LOGO BNS HAD FOREIGN MATTER IN THE SYRINGE BARREL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4) BATCH NO: 0022965 IT WAS REPORTED THAT THERE ARE CLEAR PLASTIC PARTICLES WITHIN THE SYRINGE BARRELS. AS ADDITIONAL INFORMATION, WE HAVE FOUND PARTICLES OF THIS TYPE IN EACH AND EVERY LOT OF THESE BARRELS THAT WE HAVE RECEIVED OVER THE PAST SEVERAL YEARS. WE ROUTINELY REMOVE THEM AS PART OF OUR ASSEMBLY AND INSPECTION PROCESSES. IN THIS CASE HOWEVER, THE AMOUNT OF PARTICLES WITHIN THE LOT HAS BEEN SUBSTANTIALLY HIGHER THAN IN PREVIOUS LOTS, AND HAS LED TO DIFFICULTIES IN REMOVING THEM IN ORDER TO BE ABLE TO USE THE BARRELS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BARREL 10CC LL W/SILICONE NO BD LOGO BNS HAD FOREIGN MATTER IN THE SYRINGE BARREL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 304157, BATCH NO: 0022965. IT WAS REPORTED THAT THERE ARE CLEAR PLASTIC PARTICLES WITHIN THE SYRINGE BARRELS. AS ADDITIONAL INFORMATION, WE HAVE FOUND PARTICLES OF THIS TYPE IN EACH AND EVERY LOT OF THESE BARRELS THAT WE HAVE RECEIVED OVER THE PAST SEVERAL YEARS. WE ROUTINELY REMOVE THEM AS PART OF OUR ASSEMBLY AND INSPECTION PROCESSES. IN THIS CASE HOWEVER, THE AMOUNT OF PARTICLES WITHIN THE LOT HAS BEEN SUBSTANTIALLY HIGHER THAN IN PREVIOUS LOTS, AND HAS LED TO DIFFICULTIES IN REMOVING THEM IN ORDER TO BE ABLE TO USE THE BARRELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808682 BARREL 10CC LL W/SILICONE NO BD LOGO BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0022965

    Patients

    Seq Age Sex Outcome Treatment
    1 Other