Investigation: a sample is not available for evaluation.Observations and testing could not be performed because units were not received for investigation.A dhr review was performed on the lot number 7200605.The lot number was built on afa line 10, from july 26, 2017 thru july 30, 2017.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.In process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Conclusions: the defect needle retraction failure, as stated as the reported code 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.Without a unit for evaluation; there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.Did the evaluation confirm the customer¿s experience with the bd product? no; unable to confirm the customer¿s experience because units were not returned for evaluation and testing.Were we able to reproduce the customer's experience with the bd product? no; unable to reproduce the customer¿s experience because units were not returned for evaluation and testing.Was the device used for treatment or diagnosis?.
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