Per review of the dhr it was concluded that all required challenge samples and testing was performed per specifications, in accordance with the in-process sampling plans.Review disclosed there was no indication of the alleged defect as there was one non-related qn initiated and no reject activity findings throughout the build of this lot that would impact upon the quality of the product relevant to the defect stated in the pir.Observations and testing could not be performed because units were not provided for investigation.Confirmation of the defect as stated in the product incident report, could not be identified or confirmed and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.This incident is indeterminate.Relationship of device to the reported incident: indeterminate the defect described in the product incident report was not confirmed or replicated; as units were not provided for this incident, therefore a definite root cause could not be established.
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