BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7534411 · Received May 22, 2018

    Report

    Report Number
    3002682307-2018-00134
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 1, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED A SAMPLE OR PHOTO TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS NOT ABLE TO VERIFY THE REPORTED ISSUE OF PLUNGER/TIP LEAKAGE. 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 Nº2028 (FEBRUARY 27TH - 28TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8057704 (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 #8058724, AND #8050842 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8058729, AND #8050852 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: BASED ON THE NONCONFORMANCE DESCRIPTION, WE THINK THAT THE ISSUE REGARDING TIP LEAKAGE, COULD BE RELATED WITH SOME INEFFECTIVE LUER SLIP FITTING BETWEEN THE SYRINGE TIP AND THE DEVICE USED IN CONNECTION TO THE SYRINGE. ABOUT THE LEAKAGE FROM THE PLUNGER, 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. BASED ON OUR PREVENTIVE MEASURES AND THE NUMEROUS QUALITY INSPECTIONS WE ARE CONFIDENT THAT THE LEVEL OF DEFECTS IN OUR PROCESS IS VERY LOW. CAPA DETERMINATION: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 DISCARDIT¿ II SYRINGE WITH INTEGRATED HOLDER THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿RECURRENT LEAKS FROM THE PLUNGER TIP AND FROM THE SYRINGE TIP (WHERE THE NEEDLE ADAPTS).¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378197 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802308

    Patients

    Seq Age Sex Outcome Treatment
    1 Other