BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7265407 · Received February 12, 2018

    Report

    Report Number
    3002682307-2018-00024
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 29, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: SAMPLE EVALUATION N/A. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2023 (B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4203, Nº4213, AND Nº4212, IN LOT #7258083 ( (B)(6) 2017) . RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7258042, #7251465, #7244050, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7258043, #7251468, AND #7244051 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS BASED ON THE CUSTOMER DESCRIPTION, WE CONSIDER THAT THE PARTICLES INSIDE THE SYRINGE COULD BE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. THE 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 STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. THE PRESENCE 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 PRIOR TO MARKETING THE PRODUCT AND MEET THE ESTABLISHED CRITERIA FOR PRECLINICAL TOXICOLOGICAL SAFETY EVALUATIONS. SHOULD ANY LUBRICANT PARTICLES ENTER THE FLUID PATHWAY THEN THE RISK TO THE PATIENT BASED ON TOXICOLOGICAL OR PHYSICAL OCCLUSION OF BLOOD VESSELS IS DEEMED AS NEGLIGIBLE AND CLINICALLY INSIGNIFICANT. CONFIRMATION NO SAMPLES RETURNED FOR EVALUATION. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE HAD VISIBLE FOREIGN MATTER IN THE FLUID PATHWAY. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106124 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1709218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other