(b)(4).One (1) used set with packaging was returned for evaluation.Upon visual examination of the returned set, the macro valve on line 1 was observed to be slightly turned.Although macro line 1 was slightly turned, the position of the valve indicates that the valve was placed on the pump and leak checked by the pump.Therefore, the reported defect of skewed valve was not confirmed.Additionally, the retain samples were visually examined with passing results.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for future reference and continue to monitor other reports for similar occurrences.
|