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 product was within specifications.Review of the sterilization certificate for the tray lot revealed that the product was processed according to validated specification requirements and parameters.Smiths 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 trends for the drug lot numbers, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on the available evidences and investigation results the reported by the customer complaint could not be confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
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