BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE S2

    MDR report key: 8156689 · Received December 12, 2018

    Report

    Report Number
    3002682307-2018-00312
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 23, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1805176; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-05-03. MEDICAL DEVICE LOT #: 1802286; MEDICAL DEVICE EXPIRATION DATE: 2023-01-31; DEVICE MANUFACTURE DATE: 2018-02-21 . MEDICAL DEVICE LOT #: 1803194; MEDICAL DEVICE EXPIRATION DATE: 2023-02-28; DEVICE MANUFACTURE DATE: 2018-03-19. MEDICAL DEVICE LOT #: 1805261; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-05-14. (B)(6). DHR REVIEW: (B)(4): 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 Nº2022 (MAY 11TH - 12TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8127719. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8128591, #8119953, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8128595, #8119957, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. (B)(4): 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 Nº2022 (FEBRUARY 20TH ¿ 21ST, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8050712, #8036713, #8043943. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8050843, #8043960, #8037758, #8030577, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8050853, #8043964, #8037765, #8030581, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. (B)(4): 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 Nº2022 (MARCH 19TH - 20TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8075964, #8071863. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8075987, #8072878, #8065745, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8075991, #8072883, #8065749, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. (B)(4): 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 Nº2022 (MAY 23RD - 24TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8141661. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8142763, #8135533, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8142767, #8135537, #8128595, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. INVESTIGATION SUMMARY: OUR MANUFACTURING FACILITY WAS PROVIDED WITH FIVE SAMPLES FOR INVESTIGATION. UPON EXAMINING THE PRODUCT, WE WERE ABLE TO VERIFY THE PRESENCE OF WHITE PARTICLES INSIDE THE SYRINGE. A BATCH HISTORY WAS PERFORMED FOR THE REPORTED BATCHES, 1805176,1802286,1803194, AND 1805261, WHICH SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION ANY OF THE THESE BATCH NUMBERS. THROUGH OUR INVESTIGATION THE PARTICLES WERE IDENTIFIED TO BE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. THIS LUBRICANT IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2-PIECE SYRINGES. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL/EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPE LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. THE PRESENCE OF PARTICLES OF LUBRICANT IN THE FLUID PATH OF DISCARDIT II SYRINGES HAS BEEN EVALUATED BY BD. THE POLYPROPYLENE USED TO PRODUCE THE SYRINGE BARRELS (WITH THE SLIP AGENT INCLUDED IN THE FORMULATION) HAS PASSED ALL THE BIOCOMPATIBILITY TESTS REQUIRED. INVESTIGATION CONCLUSION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. AFTER THE EVALUATION OF THE RETURNED SAMPLES, WE CONFIRMED THE REPORTED ISSUE, AND CONCLUDED THAT THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. ROOT CAUSE DESCRIPTION : PARTICLES COMPOSED BY LUBRICANT, WHICH IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2 PIECE SYRINGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGES S2 HAD FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997934 BD¿ SYRINGE S2 SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other