The date received by manufacturer has been used for this field.Investigation: customer complaints about the needle exposure of the n35 injector.The picture received confirms the defect.The grips of the safety sleeve are not placed just below the grips of the piston, and the injector is activated: that is why the needle is exposed.Three retained samples have been checked and no defects have been found.The injectors have been activated and connected to a protector and also to c100 infusion adapter and no needle exposure has been shown.It is recommended to carefully follow the instructions explained in the ifu.It is important to hold onto the white part of the injector before engaging/disengaging.Do no touch the blue part: if grips of the safety sleeve are removed from their place, the injector is activated and cannula causing needle exposure.The defect can be caused if the blue part of the injector (safety sleeve) is used to connect /disconnect the part to/from the protector.The injector must be removed pulling it back: if it is removed without doing this the grips are removed from their place, safety sleeve broken and needle exposure happens.Device history record has been checked and no quality notifications or other events have been found.Several inspections take place during manufacturing process in order to verify the quality of the product.Among them, critical to quality dimensions of all injector components are measured to check if the dimensions are within tolerance.Also, the functionality of the grips nd cylinder assembly are verified.After the evaluation of the sample and the description of the complaint, the most possible root cause is a bad handling of the device.Only in that way it is possible to duplicate the defect.(b)(4).
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