Visual evaluation of marcaine-bupivacaine ampules from ten trays, returned by the customer, found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vial.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, performed by the supplier prior to release of bupivacaine-marcaine lot # 700503a, was within specification.Review of the sterilization certificate for the tray lot number 3387507 (po # (b)(4)) revealed that the product was processed according to validated specification requirements and parameters.Smith medical periodically monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.Our records show that the supplied drugs components continue to meet potency specifications.Complaint history review does not indicate any upward trends for the drug lot number, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
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