BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7142624 · Received December 22, 2017

    Report

    Report Number
    3002682307-2017-00134
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 24, 2017
    Report Date
    January 4, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BD RECEIVED A SAMPLE FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLE WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE REPORTED LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: 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.

    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. AFTER THAT WE COULD DETERMINE DAMAGE IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. 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 Nº2023 ((B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4213, Nº4203, Nº4212, AND Nº4235, IN LOT #7258083, #7237288, #7251003. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7258042, #7251465, #7244050, #7237224, AND #7234192 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7258043, #7251468, #7244051, #7237228, #7234196, AND #7237228 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 BD DISCARDIT¿ II SYRINGE LEAKED AIR AND LIQUID PAST THE PLUNGER DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924085 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1708139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other