BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ WITH NEEDLE

    MDR report key: 7549773 · Received May 29, 2018

    Report

    Report Number
    3002682307-2018-00125
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 14, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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: WE HAVE BEEN PROVIDED WITH ONE REFERENCE SAMPLE. WE PERFORMED THE LEAKAGE TEST FOR THIS PROVIDED SAMPLE AND ANY DEFECT WAS DETECTED. WE COULD NOT CONFIRMED THE REPORTED ISSUE. 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 Nº2026 (JUNE 15TH - 17TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, AND Nº4201, IN LOT #7156015 (JUNE 5TH ¿ 12TH, 2017), AND IN LOT7160155 (JUNE 12TH ¿ 21ST, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7160132, #7156059, AND #7145303 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7160136, #7156064, AND #7145308 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 THERE IS NO 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. 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 A BD SYRINGE¿ WITH NEEDLE LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393889 BD SYRINGE¿ WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1706205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other