BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7252940 · Received February 8, 2018

    Report

    Report Number
    3002682307-2018-00020
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 15, 2018
    Report Date
    January 25, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    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 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. THE AMOUNT OF PARTICLES WAS NOT VERY HIGH AND ALL OF THEM WERE OUTSIDE THE FLUID PATH. 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 Nº2024 ( (B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, AND Nº4220, IN LOT #7251002 ( (B)(6) 2017) AND IN LOT #7258082 ( (B)(6) 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7251464, #7244048, #7237223, AND #7258040 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7251467, #7244049, AND #7258041 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS 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 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 THE RETURNED SAMPLES PRESENTED SMALL WHITE PARTICLES IN THE SYRINGE AND CONFIRMED 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 THE DISCARDIT¿ II SYRINGE ¿HAD AN ABRASION, VISIBLE WITH THE NAKED EYE, FOUND WITHIN THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101362 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1709190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other