Qn# (b)(4).The customer returned a sheath/dilator assembly for evaluation.No anomalies or defects were found during the visual inspection.The hemostasis valve opening inner diameter was measured and was found to be within specification; however, the dilator hub distal base was not within specification per dilator drawing.To functionally test the two components, the returned dilator was inserted into the returned sheath hub.The dilator did not snap into place and could be easily removed from the sheath hub.A device history record review was performed on the sheath and dilator with no relevant manufacturing findings identified.The reported complaint that the dilator does not lock into the sheath was confirmed through testing of the returned sample.The returned components were functionally tested and the dilator would not lock into the sheath.Dimensional testing was performed and determined that the cause of the issue was the dilator hub outer diameter being undersized.Device history records were reviewed with no evidence to suggest a manufacturing related cause.Based on this investigation, the probable cause of this complaint is manufacturing related.A non-conformance request has been initiated to further investigate this complaint issue.
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