Based on analysis and conducted measurements some exceedances on parameter responsible for correct connections between safety needle and syringe were observed, but a reason of defect can be unrelated to the manufacture.A reason of correct connections between safety needle and syringe may be resulted by misuse.Additionally, accordingly to conducted empirical test based on instruction for use, if the safety needle is firmly seated on syringe as it is recommended by ifu and connection is verified by the user, then no problem with proper connection should occurred.We underline the necessity to following proper use as it shared on ifu from safety syringe to avoid problem connected the needle between the syringe.Regarding leakage on the plunger side, a leakage test was performed: water was draw into the syringe, needle tip was blocked by the gasket and the plunger was pushed in purpose to create the pressure and check the leakage issue.As the result no water leakage occurred.Regarding dull needle and bent needle from the user end, the puncture force test was made and rigidity test accordingly to iso 7864.All needles passed the test.Additionally, needle tip were observed under magnification.No hooks, burrs or damages of were observed.No deviations were observed.Regarding the blue safety caps breaks off when user attempts to cover the needle, an activation test was made.No deviations were observed.Each attempt succeeded.
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