Investigation summary: lot analysis: review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Visual analysis: observations and testing could not be performed because units were not received for investigation of this incident.Investigation conclusion: the defects catheter broke / separated before placement, needle penetration difficult / painful and needle retraction fast; as stated as the reported codes 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.Root cause: relationship of device to the reported incident: indeterminate.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.
|