BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD DISCARDIT¿ II SYRINGE

    MDR report key: 7249719 · Received February 7, 2018

    Report

    Report Number
    3002682307-2018-00014
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 12, 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 · 0

    INVESTIGATION RESULTS: AN INVESTIGATION WAS COMPLETED USING THE AFFECTED SAMPLES THAT HAVE BEEN RETURNED. THE WHITE PARTICLES INSIDE OF THE SYRINGE WERE COMPOSED OF LUBRICANT FROM THE SYRINGE BARREL. THE AMOUNT OF PARTICLES WAS NOT VERY HIGH AND ALL OF THEM WERE OUTSIDE OF THE FLUID PATH. THIS VERIFIES THE REPORTED ISSUE. 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 (B)(4) (SEPTEMBER 7 - 8TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7244146 (SEPTEMBER 4 - 17TH, 2017) . RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7244052, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7251469, #7244053, #7237230, #7211171, AND #7234129 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 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. 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 THROUGH CAPA #(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6) . 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 FOREIGN MATTER WAS FOUND IN THE FRONT OF THE PLUNGER INSIDE THE SYRINGE BARREL OF A 20 ML BD DISCARDIT¿ II SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90945 20 ML BD DISCARDIT¿ II SYRINGE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1709128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other