BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE E/T EMERALD

    MDR report key: 8206733 · Received December 31, 2018

    Report

    Report Number
    3002682307-2018-00338
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 11, 2018
    Report Date
    January 9, 2019
    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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- 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 PACKAGED IN MACHINE Nº2017 (MARCH 8TH ¿ 9TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, IN LOT #8065549 (MARCH 6TH ¿ 15TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8062923, #7258069, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE AND FIVE REFERENCE SAMPLES. VISUAL INSPECTION OF THE RETURNED AFFECTED SAMPLE PRESENTED A CRACK ON THE BARREL WALL. THAT CONFIRMED THE REPORTED ISSUE. NO ISSUE FOUND FOR THE RETURNED REFERENCE SAMPLES. AFTER ANALYZING THE RETURNED THE SAMPLE AND DISCUSSING WITH OUR MANUFACTURING TECHNICIANS IN CHARGE OF THESE PRODUCT LINES, WE HAVE CONCLUDED THAT THE BROKEN BARREL WAS PRODUCED IN THE PRIMARY PACKAGING MACHINE, IN THE SYRINGE FEEDER STATION, DUE TO AN INCORRECT ALIGNMENT OF THE SYRINGE PRODUCED THE RUPTURE OF THE BARREL. CONCLUSION(S): THE BARREL WAS BROKEN DURING THE MANUFACTURING PROCESS DUE TO AN INCORRECT ALIGNMENT OF THE SYRINGES IN THE FEEDER OF THE PRIMARY PACKAGING MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE E/T EMERALD WAS CRACKED.

    Additional Manufacturer Narrative · 1

    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 THAT BD¿ SYRINGE E/T EMERALD WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045055 BD¿ SYRINGE E/T EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1803152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other