BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE S2 2ML

    MDR report key: 7481026 · Received May 2, 2018

    Report

    Report Number
    3002682307-2018-00108
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 7, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. WE COULD NOT DETERMINE THE EXACT ROOT CAUSE DUE TO THE PRESENCE OF DRUGS INSIDE THE SYRINGES. THE SAMPLES WERE NOT DECONTAMINATED. 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 Nº2025 (JULY 25 - 28TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4219, Nº4214, Nº4207, Nº4206, AND Nº4201, IN LOT #7206427 (JULY 25 - 26TH, 2017), AND IN LOT #7202260 (JULY 24 - 31ST, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7202240, AND #7198281 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7187014, #7198287, #7202241, AND #7205025 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: BASED ON THE NONCONFORMANCE DESCRIPTION, WE THINK THAT THE ISSUE COULD BE RELATED WITH SOME INEFFECTIVE LUER SLIP FITTING BETWEEN THE SYRINGE TIP AND THE DEVICE USED IN CONNECTION TO THE SYRINGE. BASED ON OUR PREVENTIVE MEASURES AND THE NUMEROUS QUALITY INSPECTIONS WE ARE CONFIDENT THAT THE LEVEL OF DEFECTS IN OUR PROCESS IS VERY LOW. IN BD FRAGA, THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100 % THE SYRINGES, REJECTING AUTOMATICALLY THE DEFECTIVE ONES, SUCH AS: CRACKED BARREL, MISSING COMPONENTS, HARD SLIDING PERFORMANCE, NOTICEABLE LEAKAGE THROUGH THE PLUNGER, ETC. CONFIRMATION: THE PROVIDED SAMPLES WERE NOT ABLE TO BE TESTED. NO LEAKAGE FROM TIP WAS IDENTIFIED. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP OF A BD¿ SYRINGE S2 2ML LEAKED WHEN IN USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324119 BD¿ SYRINGE S2 2ML SYRINGE FMF BECTON DICKINSON, S.A. 1707110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other