(b)(4).A device history record review was performed on the epidural catheter, stylet, and needle with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the catheter, the catheter stylet, and needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of difficulty threading the catheter could not be determined based upon the information provided and without a sample.
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