BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SYRINGES BD DISCARDIT¿ II

    MDR report key: 6937662 · Received October 10, 2017

    Report

    Report Number
    3002682307-2017-00074
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    November 6, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: A DEVICE HISTORY REVIEW WAS PERFORMED ON LOTS 1704189, 1703294, 1703018, 1704192, 1704212, 7114312, 7114316, AND 7100040. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. 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 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE # (B)(6). FIVE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1701489, MEDICAL DEVICE EXPIRATION DATE: 03/31/2022, DEVICE MANUFACTURE DATE: 04/27/2017. MEDICAL DEVICE LOT #: 1703294, MEDICAL DEVICE EXPIRATION DATE: 02/28/2022, DEVICE MANUFACTURE DATE: 04/05/2017. MEDICAL DEVICE LOT #: 1703108, MEDICAL DEVICE EXPIRATION DATE: 02/28/2022, DEVICE MANUFACTURE DATE: 02/27/2017. MEDICAL DEVICE LOT #: 1704192, MEDICAL DEVICE EXPIRATION DATE: 03/31/2022, DEVICE MANUFACTURE DATE: 04/27/2017. MEDICAL DEVICE LOT #: 1704212, MEDICAL DEVICE EXPIRATION DATE: 03/31/2022, DEVICE MANUFACTURE DATE: 05/02/2017. 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 CONTAMINATION ¿ABRASION/DUST¿ WAS FOUND ON SOME UNUSED DISPOSABLE SYRINGES BD DISCARDIT¿ II PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718362 DISPOSABLE SYRINGES BD DISCARDIT¿ II SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other