Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Two samples were received for evaluation.The samples were received in new condition with its original closed packaging.During functional testing, a syringe was filled with colored water to detect any occlusion.During the test, the water did not pass-through filter.The complaint is confirmed.Continue with the analysis, tried to replicate the failure mode.Based on the tests results, it is concluded that the failure could be reproduce in two ways: when the excess of solvent is not cleaned before to assembly the tube with the component or when the tube is introduced two times in the solvent dispenser (procedure is not followed).Excess of solvent was caused by not following the procedure.An alert was generated to ensure adherence to manufacturing procedure related to cleaning the excess solvent before to assembling the tube and the component.
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