Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Visual evaluation of one bupivacaine ampule from the returned tray found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vial.The anesthetic is a supplied items and the complaint notification was forwarded to the supplier.Records analysis was performed by the supplier for bupivacaine lot #'s 57-237-ev and confirmed that the reported lot continues to meet all specifications.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
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