A device history record (dhr) review was performed on the epidural catheter and epidural needle and there were no issues found that could relate to the reported complaint.A review of change history data over the past two years was performed on the kit, the epidural catheter, and the epidural needle, with no material changes found that could have led to the reported complaint.Complaint verification testing could not be performed as no sample was returned for analysis.The device history records for the epidural catheter and the epidural needle were reviewed with no evidence to suggest a manufacturing related cause.The potential cause of difficulty threading the epidural catheter through the epidural needle could not be determined.If the sample is returned, a follow-up report will be submitted with investigation results.
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