H.6.Investigation summary: device/batch history record review findings: review was performed on the lot number 5232532.The product was manufactured on afa line 6 from august 27, 2015 thru august 31, 2015 and packaged on packaging line 11 from september 1, 2015 thru september 2, 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 upon the quality of the product.Set-up and in-process inspections included but were not limited to blister thickness, bad seal/cut/holes, seal transfer width and package leak test.These were performed on various stages throughout the process, all the inspections passed per specifications.No significant issues were found during the review of the device history record.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Observations and testing: received one unused iag 14ga unit in partially opened package from the lot number; 5232532.Visual/microscopic examination: the package was partially opened at the top of the blister pack.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.Per observation of the photos provided this characteristic was met.In addition, the bottom web in the photos revealed evidence of adequate transfer (adhesive) from the paper top web at the open seals and partially open seals of the packages (blister packs).The key variables that affect seal strength are: seal transfer/width and top web adhesive presence.Both of these variables were looked at during the investigation.Conclusions: the defect package seal integrity poor/questionable, stated in the description of the complaint was confirmed with the returned unit.Even though the package was partially opened, all the process characteristics that directly influence the seal were observed to be within specification.There was no physical evidence to confirm or to support manufacturing process related issues for the defect.Capa 48637 was initiated to address the issue of open seal complaints.Tasks associated with the capa plan have been completed.
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