BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 7495280 · Received May 8, 2018

    Report

    Report Number
    3002682307-2018-00115
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 16, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 RESULTS: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. THE PROVIDED SAMPLE PRESENTED YELLOW SPOT OF FOREIGN MATTER IN THE PLUNGER ROD, ALSO SMALL PARTICLES IN THE BODY OF THE SYRINGE. WE COULD NOT DETERMINE THE EXACT ROOT CAUSE OF THIS REPORTED ISSUE DUE TO THE CONDITIONS OF THE SAMPLE. 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 Nº2011 (SEPTEMBER 7 - 8TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT#: 7244146 (SEPTEMBER 4 - 17TH, 2017) . RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS#: 7244052, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS#: 7251469, #7244053, #7237230, #7211171, AND #7234129 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: THE ACCURATE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. DESPITE THE FACT THAT ANY HIGH VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. IN BD FRAGA, THE WHOLE PROCESS TO ASSEMBLE AND PACKAGE THE PRODUCT TAKES PLACE IN AN ENVIRONMENTALLY CONTROLLED ROOM WHERE THE AIR IS CONTINUOUSLY FILTERED USING A HEPA FILTER SYSTEM. CONFIRMATION: THE PROVIDED SAMPLE PRESENTED FOREIGN MATTER INSIDE THE SYRINGE. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL. 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 WITH THE USE OF THE BD 20 ML SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH SCALE MARKING ERROR. IT WAS STATED ¿THE NURSE FOUND YELLOW FOREIGN MATTER AND WHITE FOREIGN MATTER IN TWO SYRINGE BARRELS RESPECTIVELY AFTER OPENING THE PLASTIC PACKAGES.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335945 BD 20 ML SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1709128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other