BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2ML BD DISCARDIT¿ II SYRINGE

    MDR report key: 6774279 · Received August 8, 2017

    Report

    Report Number
    3002682307-2017-00021
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 18, 2017
    Report Date
    October 11, 2017
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH TEN SAMPLES. THE RETURNED SAMPLES DID NOT PRESENT ANY FOREIGN MATTER PARTICLE INSIDE THE SYRINGE. WE CONSIDER THAT THE PARTICLES FOUND BY THE CUSTOMER COULD BE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. BHR REVIEW: LOT 1511165: 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 Nº2026 (NOVEMBER 11 - 14TH, 2015). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, Nº4201 AND Nº4206, IN LOT #5313259. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. LOT 1602209: 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 Nº2026 (FEBRUARY 23 - 26TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, Nº4201 AND Nº4206, IN LOT #6053199. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. LOT 1702233: 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 Nº2025 (FEBRUARY 22 - 25TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, Nº4201 AND Nº4206, IN LOT #7048465, #7041325. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. 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: THE RETURNED AFFECTED SAMPLE DID NOT PRESENT ANY FOREIGN MATTER ISSUE. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1511165 MEDICAL DEVICE EXPIRATION DATE: 2020-10-31 DEVICE MANUFACTURE DATE: 2015-11-05; MEDICAL DEVICE LOT #: 1602209 MEDICAL DEVICE EXPIRATION DATE: 2021-01-31 DEVICE MANUFACTURE DATE: 2016-02-17; MEDICAL DEVICE LOT #: 1702233 MEDICAL DEVICE EXPIRATION DATE: 2022-01-31 DEVICE MANUFACTURE DATE: 2017-02-21. (B)(6). FOR DEVICES WITHOUT 510(K) NUMBERS: PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE OF A 2ML BD DISCARDIT¿ II SYRINGE BEFORE USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555665 2ML BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. MULTIPLE - SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other