BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7231249 · Received January 31, 2018

    Report

    Report Number
    3002682307-2018-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 8, 2018
    Report Date
    February 28, 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 · 0

    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 QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (SEPTEMBER 4 - 5TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7234165 (AUGUST 23 - 28TH, 2017), IN LOT #7237287 (AUGUST 28TH - SEPTEMBER 4TH, 2017) AND IN LOT #7244144 (SEPTEMBER 4 - 11TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7234125, #7202242, #7211165, #7244048, AND #7237223 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7234127, #7211169, #7244049 AND #7237227 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).

    Additional Manufacturer Narrative · 1

    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 DURING USE A BD DISCARDIT¿ II SYRINGE WAS FOUND WITH FOREIGN MATTER AS ¿EXTRA PLASTIC PIECES ¿WERE FOUND INSIDE THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75519 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1709119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other