BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE

    MDR report key: 6860042 · Received September 12, 2017

    Report

    Report Number
    3002682307-2017-00040
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 18, 2017
    Report Date
    October 3, 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ROOT CAUSE ANALYSIS: WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS 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. 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 DETERMINATED A DAMAGED 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 Nº2011 (SEPTEMBER 14 - 15TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #6249011 (SEPTEMBER 7 - 17TH, 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6249468, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6253447, #6249472, AND #6239284 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE PLUNGER OF THE BD 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE, DURING USE. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637506 BD 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE 301948 FMF BECTON DICKINSON, S.A. 1609154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other