Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.A review of the device history records and the microbiological tests (pyrogens) in the certificate of sterility, all the units (b)(4) meet with acceptance criteria.Testing revealed no irregularities during the manufacture and sterilization of reported lot number 7115948.Without sample or photo we could not confirm or associate the reported defect to manufacturing process.We could not find a definitive root cause, since no sample or photo was returned for evaluation.No capa was opened since this issue could not be confirmed as manufacturing related.
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