This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.G5 510k is unknown.No information has been provided to date.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.One sample was received in used conditions without its original packaging.The sample was received with the tube cut.The sample was visually inspected with a 12 to 24 inches distance under normal conditions of illumination.During the visual inspection, excessive solvent was found in the tube.During functional testing he sample was tested using the blow-through/test station, the sample did not pass the test, air did not pass through the tube.The root cause was related to manufacturing process.As a preventive action manufacturing personnel were notified as an awareness of the failure mode reported by the customer.
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