H.6.Investigation summary: device/bath history review findings: as this complaint was an mdr, dhr review was performed on the lot number 5219921.The product was manufactured on afa line 9 from august 13, 2015 thru august 14, 2015 and packaged on packaging line 11 from august 21, 2015 thru august 21, 2015.Review of the dhr¿s revealed all required challenges samples and testing was performed per specification in accordance with the set-up and 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 the quality of the product.Set-up and in-process inspections (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test.These were performed on various stages throughout the process and all the inspections passed per specifications.Visual analysis: observations and testing: received 15 unused iag/bc 16ga units in partially opened package from the lot number 5219921.Visual/microscopic examination: two of the packages were partially opened at both ends of the blister pack.Two of the packages were partially opened at the top of the blister pack.Two of the packages were partially opened at the bottom of the blister pack.The seals of the remaining nine packages were not compromised.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition, the paper top web of the returned unit was analyzed.The analysis revealed an adequate of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were looked at during the investigation.Investigation conclusion: relationship of device to the reported incident: indeterminate.Comment: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.
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