BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20ML DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 7079188 · Received December 4, 2017

    Report

    Report Number
    3002682307-2017-00114
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 21, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1705177, EXPIRATION DATE: 2022-04-30, MANUFACTURE DATE: 2017-05-11. MEDICAL DEVICE LOT #: 1704131, EXPIRATION DATE: 2022-03-31, MANUFACTURE DATE: 2017-04-10. MEDICAL DEVICE LOT #: 1706151, EXPIRATION DATE: 2022-05-31, MANUFACTURE DATE: 2017-06-13. INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION: 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. BHR REVIEW: LOT 1705177: 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 Nº(B)(4) (MAY 18 - 26TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº(B)(4), IN LOT #7132498 (MAY 15 - 22ND, 2017) AND IN LOT #7139351 (MAY 22 - 29TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7139232, #7132416, #7125070, AND #7118054 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7139237, #7132420, #7125075, AND #7118055 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. LOT 1704131: 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 Nº(B)(4) (APRIL 2 - 3RD, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7083154. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. 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. LOT 1706151: 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 Nº(B)(4) (JUNE 15 - 16TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7160161. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOT #7160135, #7156062, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7160139, AND #7156067 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 DISCARD IT 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 WHITE PARTICLES IN THE SYRINGE AND CONFIRMED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE 20ML DISCARDIT¿ II SYRINGE W/O NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860357 20ML DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other