BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II ¿ SYRINGE WITH NEEDLE

    MDR report key: 7410945 · Received April 10, 2018

    Report

    Report Number
    3002682307-2018-00075
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 18, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BD HAS NOT BEEN PROVIDED A PICTURE OR AFFECTED SAMPLE FOR THIS RECORD. UNFORTUNATELY AS A RESULT, BD IS NOT ABLE TO VERIFY THE REPORTED ISSUE. BD CONCLUDES THAT THE REPORTED ISSUE 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 AND THE POSSIBILITIES OF LEAKAGE IS VERY LOW. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. SAMPLE EVALUATION: N/A. 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 Nº2011 (SEPTEMBER 10TH ¿ 11TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4251, AND Nº4252, IN LOT #7244146 (SEPTEMBER 4TH - 17TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7244052 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7251469, #7244053, #7237230, #7211171, AND #7234129 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: WE HAVE NOT BEEN ABLE TO ESTABLISH THE SPECIFIC ROOT CAUSE THEREBY INCUR THE REPORTED ISSUE. WE CONCLUDE THAT THE REPORTED ISSUE 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. WE MUST TAKE INTO ACCOUNT THAT IT IS NOT POSSIBLE TO HAVE 100% LEAKAGE FREE WHEN WE USE TWO PIECES SYRINGES. ON THE OTHER HAND, BASED ON OUR PREVENTIVE MEASURES AND THE NUMEROUS QUALITY INSPECTIONS WE ARE CONFIDENT THAT THE LEVEL OF DEFECTS IN OUR PROCESS IS VERY LOW.

    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 THAT A NURSE FOUND LEAKAGE ON A BD¿ 20 ML SYRINGE WITH NEEDLE WHEN ASPIRATING LIQUID. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253896 BD DISCARDIT II ¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1709144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other