BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 5ML SYRINGE

    MDR report key: 7035472 · Received November 15, 2017

    Report

    Report Number
    3002682307-2017-00103
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 8, 2017
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED SAMPLES. WE COULD NOT DETERMINATE THE EXACTLY ROOT CAUSE DUE TO THE PRESENCE OF DRY BLOOD INSIDE THE SYRINGES. 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 QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2020 ((B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, AND Nº4220, IN LOT #7023219 (JANUARY 23 - 30TH, 2017), IN LOT #7030005 (JANUARY 30TH - FEBRUARY 6TH, 2017), AND IN LOT #7034456 (FEBRUARY 6 - 13TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7031187, #7024019, #7016113, AND #7034436 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7031191, #7024023, #7016117, AND #7034440 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONFIRMATION: THE PROVIDED SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM A BD¿ 5ML SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815391 BD¿ 5ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1702185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other