Two originally sealed portex® single shot epidural trays were returned for analysis.No visible non-conformities were found during visual evaluation.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing was found to be within specification.A review of the sterilization certificate was reviewed and found within specification.Records were reviewed and deemed adequate.Based on the evidence, the root cause is unknown as the complaint is not confirmed.
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