This mdr was generated under protocol b10009704, as a result of warning letter cms#: 617147.510k 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 (1) sample was received from its closed original packaging in new conditions.Visual inspection was performed at 12 under normal lighting to received unit.During the visual inspection, it was seen that the box label and the lid label did not match.The information for use inside the box was reviewed and it was correct according to its label.The product inside the tray was observed and all the components were correct according to its label.The most probable root cause was that after a review of the different verifications that are performed during the manufacturing process to detect mixing components and since the products were manufactured with two years of difference, the most probable root cause was that mixing occurred after the product left the facility.The following actions were taken: as a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.
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