BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE EMERALD BNS

    MDR report key: 7307934 · Received March 1, 2018

    Report

    Report Number
    3002682307-2018-00037
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 7, 2018
    Report Date
    February 8, 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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: OUR MANUFACTURING FACILITY RECEIVED FIVE AFFECTED SAMPLES THAT WERE USED FOR OUR INVESTIGATION. UPON INSPECTION, WE NOTED MINOR FLASHES (EXCESS PLASTIC) AT THE TOP OF THE SYRINGE. A DEVICE RECORD HISTORY REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. IT IS LIKELY THIS OCCURRED DURING MANUFACTURING IN THE INJECTION PROCESS DUE TO EITHER AN INCREASE OF THE INJECTION PRESSURE OR AN ISSUE RELATED TO THE CLOSING OF THE MOLD. THE FLASHES ARE PART OF THE MANUFACTURING PROCESS AND NOT CONSIDERED A DEFECT. IF THEY ARE WITHIN THE ESTABLISHED TOLERANCES. IN THIS OCCURRENCE IT IS CONSIDERED A COSMETIC ISSUE THAT IS NOT LIKELY TO AFFECT THE PERFORMANCE OF THE DEVICE. SAMPLE EVALUATION WE HAVE BEEN PROVIDED WITH FIVE AFFECTED SAMPLES. THE SAMPLES 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 QA NOR NCMR'S. SYRINGES WERE ASSEMBLED IN MACHINES Nº4268, Nº4259, Nº4210, AND Nº4205, IN LOT #7354988 ((B)(6) 2018) AND IN LOT #8015767 ( (B)(6) 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOT #7354647, #7353664, #7346941, #7338641, #7331822, #8015699, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. ROOT CAUSE ANALYSIS. VISUAL INSPECTION OF THE SAMPLES REVEALED SOME MINOR FLASHES ON THE TOP OF THE SYRINGE TIP. BASED ON THE SAMPLES, THESE FLASHES WERE PRODUCED IN THE INJECTION PROCESS, DUE TO A PUNCTUAL INCREASE OF THE INJECTION PRESSURE OR AN 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. 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 BURRS WERE FOUND ON THE TIP OF THE BD SYRINGE EMERALD BNS. THE MOLDING DEFECT WAS FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151811 BD SYRINGE EMERALD BNS SYRINGE FMF BECTON DICKINSON, S.A. 8010521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other