A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Investigation: one representative sample was received for evaluation.This sample was received with a little damage in the tray.Sample was visual inspected, finding no defect.Rationale: this product is assembled 100 % manually.No equipment, instrument, process and/or surfaces that could cause this kind of damage were detected.Conclusion: after evaluation of the representative sample and finding no issues of activation or an exposed cannula we were not able to associate the reported defect to the manufacturing process.Dhr did not show evidence related to the reported issue by the customer.This defect is not common in our process.Conclusion: this reported defect may be related to an incorrect device activation by user.(b)(6).(b)(4).
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