BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE EMERALD BNS

    MDR report key: 7329230 · Received March 9, 2018

    Report

    Report Number
    3002682307-2018-00060
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 14, 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
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. THE SAMPLE SHOWED FLASHES ON THE TOP OF THE SYRINGE TIP. THEREFORE, THE EVALUATION 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 QN NOR NCMR'S. SYRINGES WERE ASSEMBLED IN MACHINES Nº4268, Nº4259, AND Nº4205, IN LOT #8036716 (FEBRUARY 5 - 12TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOT #8037768, #8030583, #8022726, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. INVESTIGATION CONCLUSION: ROOT CAUSE ANALYSIS VISUAL INSPECTION OF THE SAMPLES REVEALED SOME MINOR FLASHES ON THE TOP OF THE SYRINGE TIP. THIS BARRELS WERE MANUFACTURED IN MOLD #8975 (E-5), PRESS Nº3539. BASED ON THE SAMPLES, THIS FLASHES WERE PRODUCED IN THE INJECTION PROCESS, DUE TO A PUNCTUAL ISSUE RELATED TO THE CLOSE OF THE MOLD. RELATED TO THE MINOR FLASHES ON THE TOP OF THE SYRINGE TIP, WE WOULD LIKE TO CONFIRM THAT THESE ARE PART OF THE MANUFACTURING PROCESS AND ARE NOT CONSIDERED AS A PRODUCT DEFECT IF THESE ARE WITHIN THE ESTABLISHED TOLERANCES. BASED ON OUR EXPERIENCE WITH THE PRODUCT, THIS IS A COSMETIC ISSUE, SINCE IT WOULD BE HIGHLY UNLIKELY THAT THIS MATERIAL COULD AFFECT THE PERFORMANCE OF THE DEVICE. CONFIRMATION: THE RETURNED SAMPLES PRESENTED FLASHES IN THE SYRINGE TIP. WE 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD SYRINGE EMERALD BNS ¿PIECES WITH MATERIAL OVERFLOW WERE FOUND ON THE SYRINGE TIP.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172174 BD SYRINGE EMERALD BNS SYRINGE FMF BECTON DICKINSON, S.A. 8032730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other