This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed the female lure was broken.A leak testing was performed, and no discrepancies were detected during the testing.A final audit on the visual inspection process was made, no discrepancies were observed.The training records of the operators were reviewed, and no discrepancies were found.During review of manufacturing process, a sample of 32 units was visually inspected in order to verify that the components do not present any damage; no discrepancies were found during the inspection.The most probable root cause of the reported issue was that the female lure became damaged after the product left the manufacturing facilities.Actions taken to mitigate the reported issue: as a preventive action, a notification of this complaint to the production personnel was conducted by the quality engineer.
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