BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML DISCARDIT¿ II SYRINGE WITHOUT NEEDLE

    MDR report key: 7234418 · Received February 1, 2018

    Report

    Report Number
    3002682307-2018-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 8, 2018
    Report Date
    January 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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION RESULTS: INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH (B)(4) SAMPLES FOR INVESTIGATION. AFTER INSPECTION, WE WERE NOT ABLE TO IDENTIFY ANY PRESENCE OF PLASTIC PARTICLES INSIDE THE SYRINGE. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. BASED ON THE DESCRIPTION OF THE ISSUE, WE BELIEVE IT IS LIKELY RELATED TO LUBRICANT PARTICLES. 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. INVESTIGATION CONCLUSION: WE HAVE BEEN PROVIDED WITH THE TWO REFERENCE SAMPLES. AFTER THE EVALUATION OF THE RETURNED SAMPLE, WE COULD NOT CONFIRM THE PRESENCE OF PLASTIC PARTICLES INSIDE THE SYRINGE. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. WE HAVE ALSO REVIEWED THE BARREL LOTS #7083119, AND #7076177 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7083123, AND #7076178 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION: BASED ON THE CUSTOMER DESCRIPTION OF THE ISSUE, WE THINK THAT THESE PARTICLES COULD BE COMPOSED BY LUBRICANT PARTICLES. 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. THE RETURNED SAMPLES DO NOT PRESENT ANY EXTRA PARTICLE IN THE SYRINGE. WE COULD NOT CONFIRM THE REPORTED ISSUE. WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ¿EXTRA PLASTIC PIECES¿ FOUND INSIDE TWO BOXES OF 20 ML DISCARDIT¿ II SYRINGES WITHOUT NEEDLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76799 20 ML DISCARDIT¿ II SYRINGE WITHOUT NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1707162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other