(b)(4).The customer returned a sheath extension assembly for evaluation.No anomalies or defects were found during visual inspection of either component.The hemostasis valve opening inner diameter measured 0.156", which is within the specifications of 0.154-0.156" per hemostasis valve cap drawing.The dilator hub distal base measured 0.168", which is not within the specifications of 0.169"-0.171" 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 with one relevant finding.A non-conformance was initiated for batch 34c18b0019 to address the same failure mode on lots manufactured before nov 07, 2019.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.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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