Udi is unknown.No information provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected, at a distance of 12? to 16? and normal conditions of illumination.The investigation observed the suction line was detached.20 samples were taken from the production floor of which 10 were applied tetrahydrofuran (thf) in excess and 10 followed their normal process.During evaluation testing, the reported issue was noted in all cases of the samples that had the excess of tetrahydrofuran (thf) the detachment occurred in the flange as in the received sample, in the case of the samples that did not have the excess of thf the detachment occurred under the flange and in two cases the detachment did not occur also requires more force to cause detachment.The root cause of the reported issue was excess tetrahydrofuran that was applied and lack of detection by production personnel during manufacture.Actions were taken to mitigate the reported issue: production personnel were retrained to process and procedure by the production supervisor.
|