Results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the defect of needle retraction failure.Conclusion: confirmation of the defect stated in the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pir.This root cause is indeterminate.
|