Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.Investigation summary: received one unused unit in an open package from lot number 7276764.All components were present.The unit was received along with a picture and a note from the customer.Dhr review: the lot number was built on afa line 11, from october 14, 2017 thru october 18, 2017.Per review of the dhr it was concluded that 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 foreign/non-foreign material, particulate loose or embedded were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.The white speck observed on the picture provided by the customer was confirmed to be non-foreign (plug shavings) and to have resulted from manufacturing during the assembly process.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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