Investigation summary: no non-conformance's related to the claimed defect were found during dhr review.2 unopened samples were received for investigation.Flow issues.Visual inspection shows no defects.They were connected to a vial and functional test was performed: expansion chamber worked properly and no flow issues were found.The liquid can move through the set (protector + injector + syringe) without issues.Inspections and tests the tests performed during the manufacturing process to avoid faulty parts are listed below: during molding process (according ph-300 current version): visual inspections for injector parts (cylinder, needle housing, safety sleeve, piston and membrane) are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc).Critical to quality dimensions of all injector components are measured to check if the dimensions are within tolerance.Assembly process: (according to ph-301 current version) the following visual inspections are performed by the operator: safety sleeve must be connected and should be turning with the cylinder and piston.The functionality of the grips is verified.Verify the correct welding of the membrane, color and aspect.Cylinder assembly.Piston must be fixed by the safety sleeve.Needle housing should rotate clockwise and tip of the cannula must be observed.Cannula length (with a caliper gauge).Functionality and piston welding test: quality and functionality of the membrane is verified after be welding and punctured by the cannula.As it is explained above, no flow issues were found in the 2 samples of injector received.Based on the description of the complaint, and taking into account the evaluation of the samples, the problems described seem to be an issue related to the protector use.Taking into account the description of the complaint (there was resistance and the plunger of the syringe move back.The balloon of protector did not fill with air) it seems possible that the filter was oversaturated.To avoid this, it is important to carefully follow the instructions explained in the protector ifu (dgp102).The defect was not confirmed on samples received.The defect described by the customer seems to be caused by a misuse of the device.
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