BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 7876668 · Received September 14, 2018

    Report

    Report Number
    3002682307-2018-00218
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    August 1, 2018
    Report Date
    September 24, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903077311
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED PICTURE, WE CONFIRMED THE REPORTED ISSUE, AND IDENTIFIED THE FOREIGN MATTER AS PRINTING FOIL PARTICLES IN THE FLUID PATH. WE COULD CONFIRM THE REPORTED ISSUE. DHR REVIEW FOR LOT # 1803155: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2012 (MARCH 13TH - 15TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4268, Nº4259, Nº4210, AND Nº4205, IN LOT #8071865 (MARCH 12TH ¿ 19TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8072888, #8065751, #8068611, #8058733, #7334656, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8072891, #8065754, AND #8058736 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE STOPPER LOTS #8072897, #8065761, AND #8058739 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER ANALYZING THE PICTURE OF THE AFFECTED SAMPLE PROVIDED TO THE MANUFACTURING SITE FOR EVALUATION, WE COULD SEE THE REPORTED FOREIGN MATTER AND CONFIRM THE REPORTED ISSUE. THE PROCESS USED TO PRINT THE SCALE IN BD EMERALD SYRINGES IS CALLED "HOT STAMPING" PROCESS, IN WHICH, THROUGH A HEATED METAL STAMP, THE SCALE IS TRANSFERRED FROM THE PRINTING FOIL TO THE BARREL. IN SOME CASES, THIS PRINTING FOIL DUE TO A CLOG IN THE PRINTING STATION, HAS TO BE CUT BY THE OPERATOR. WHEN THIS SITUATION HAPPENS, THE MACHINE STOPS AUTOMATICALLY AND THE OPERATOR SHOULD CUT THE PRINTING FOIL REEL TO SOLVE THE CLOG. DURING THIS CUTTING PROCESS OF THE PRINTING FOIL, SOME PARTICLES COULD REMAIN IN THE MACHINE, AND IN THIS CASE, THESE FOIL PARTICLES FINALLY ENDED IN ONE SYRINGE BARREL, PRODUCING THE REPORTED ISSUE. THE NONCONFORMANCE IS CAUSED BY A DEFECTIVE FOIL REEL AND HUMAN ERROR. WE CONCLUDED THAT IT HAS BEEN AN ISOLATED CASE WITH A NEGLIGIBLE FREQUENCY OF OCCURRENCE. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS LOW AND ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS. SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD EMERALD¿ SYRINGE, FOREIGN OBJECT WAS NOTICED IN BARREL OF SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD EMERALD¿ SYRINGE, FOREIGN OBJECT WAS NOTICED IN BARREL OF SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720140 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1803155 00382903077311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other