BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7434082 · Received April 16, 2018

    Report

    Report Number
    3002682307-2018-00104
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 24, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. THE EVALUATION OF THE SAMPLE SHOWED ONE OF THE SYRINGE FLANGES BROKEN. WE COULD CONFIRM 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 PACKED IN MACHINE Nº2024 (FEBRUARY 26 - 28TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, Nº4220, AND Nº4210, IN LOT #8050710 (FEBRUARY 19 - 26TH, 2018) AND IN LOT #8057703 (FEBRUARY 26TH - MARCH 5TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #8058723, #8050840, AND #8043957 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8058728, #8050851, AND #8043962 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: AFTER ANALYZING THE RETURNED SAMPLE AND DISCUSSING WITH OUR MANUFACTURING TECHNICIANS IN CHARGE OF THESE PRODUCT LINES, WE HAVE CONCLUDED THAT THE BARREL FLANGE BREAKAGE WAS PRODUCED IN THE ASSEMBLY STATION IN THE STACK OF THE BARREL FEEDER. THE INCORRECT ALIGNMENT OF THE BARRELS IN THIS PROCESS PRODUCED THE RUPTURED OF THE FLANGE. ON THE OTHER HAND, BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CONFIDENT THAT THIS HAS BEEN AN ISOLATED CASE AND ANY PROBABILITY OF OCCURRENCE SHOULD BE VERY EXCEPTIONAL. CONFIRMATION: THE RETURNED SAMPLE PRESENTED THE REPORTED ISSUE. 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

    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 BEFORE USE OF THE BD DISCARDIT¿ II SYRINGE THE CUSTOMER STATED ¿WHEN OPENING THE PACKAGE, ONE OF THE FLANGE PARTS WAS BROKEN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277782 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other