BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 10ML SYRINGE

    MDR report key: 6956164 · Received October 17, 2017

    Report

    Report Number
    3002682307-2017-00068
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE EVALUATION REGRETTABLY, THE AFFECTED SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE PROVIDED PICTURE OF THE SAMPLE PRESENTED A LEAKAGE THROUGH THE STOPPER, THAT CONFIRMED THE REPORTED ISSUE. BHR REVIEW: 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 Nº2015 (FEBRUARY 11 - 12TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4267, IN LOT #7034465 (FEBRUARY 6 - 12TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7034464, AND #7030012 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7034449, AND #7031199 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE STOPPER LOTS #7034454, AND #7031204 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: VISUAL INSPECTION OF THE RETURNED PICTURES OF THE SAMPLES REVEALED SOME LOOSE PARTICLES OF THE STOPPER INSIDE THE SYRINGE. BASED ON THE PICTURE OF THE SAMPLES, AND THE ABSENCE OF SIMILAR ISSUES REGARDING OUR SYRINGES, WE THINK THAT THE ISSUE COULD BE RELATED WITH SOME IMPERFECTION IN THE STOPPER OF THE SYRINGE OR THE DEGRADATION OF THE STOPPER DUE TO THE INTERACTION OF THIS STOPPER WITH THE DRUG INSIDE THE SYRINGE. BASED ON OUR EXPERIENCE WITH THE PRODUCT, THIS IS AN ISOLATED ISSUE, SINCE THE PRODUCT IS ABLE TO INTERACT WITH THE DRUGS IF THEIR CONDITIONS ARE GOOD AT THE MOMENT OF THE USE. CONFIRMATION: THE PROVIDED PICTURE OF THE SAMPLE PRESENTED LEAKAGE THROUGH THE STOPPER. WE COULD 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

    (B)(6). 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

    THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED THAT WHILE USING THE BD EMERALD¿ 10ML SYRINGE MULTIPLE TIMES, THE SYRINGE BEGAN TO LEAK. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733676 BD EMERALD¿ 10ML SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 1702393

    Patients

    Seq Age Sex Outcome Treatment
    1 Other