BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 7060108 · Received November 27, 2017

    Report

    Report Number
    3002682307-2017-00099
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 6, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION - WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED SAMPLE. WE COULD NOT DETERMINE THE EXACT ROOT CAUSE DUE TO THE PRESENCE OF DRY BLOOD INSIDE THE SYRINGE. 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 Nº2011 ((B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #7089470 ((B)(6) 2017), IN LOT #7100073 ((B)(6) 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7100035, AND #7089485 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7114316, #7100040, #7089486, AND #7083123 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 THE NURSE FOUND LEAKAGE FROM THE PLUNGER ROD OF THE BD SYRINGE WITH NEEDLE. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838985 BD SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON, S.A. 1704136

    Patients

    Seq Age Sex Outcome Treatment
    1 Other