(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no relevant findings.The customer reported the stylet does not insert correctly into the needle.The customer returned one epidural needle with stylet and guard.The returned needle visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears typical.However, after functional testing, microscopic examination revealed, the top of the needle hub is not parallel to the remaining hub as well as the needle itself.No visual defects or anomalies were observed with the returned stylet (b)(4).Functional testing was performed on the returned sample.An attempt to insert the stylet into the needle revealed the stylet hub key will not fully seat into the needle's hub.Microscopic examination revealed the notch in the stylet hub does not line up correctly with the needle's hub (b)(4).Therefore, it's not allowing the other remarks: stylet key to fully engage with the needle.Nonconformance, (b)(4), have been initiated to further investigate this complaint issue.The reported complaint of the stylet not inserting correctly in the needle was confirmed based on the sample received.Functional testing revealed the stylet key could not be fully inserted into the needle correctly due to the needle's hub not being parallel with the needle.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no evidence to indicate a manufacturing related issue.The needle is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance, (b)(4), has been initiated to further investigate this issue.
|