One epidural tray was returned for evaluation.Visual inspection of the returned device has found it to be in good physical condition.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.Assay testing, performed by the supplier prior to release of bupivacaine lot # 87-159-ev was within specification.Review of the sterilization certificate for the tray lot number 3669767 (po # 565352) 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 drug components continue to meet potency specifications.Complaint information review found no trends relevant to the drug lot number, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on available information and evidences no product quality problem could be confirmed.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
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