H.6.Investigation summary: bd received one unsued sample from the customer in support of this complaint.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.The samples were visually and microscopically evaluated and the customer's indicated failure mode for poor package seal integrity with the incident lot was not observed.Lot analysis device/batch history record review: yes findings: as this complaint was a mdr; -dhr review was performed on the lot number 6349926 the lot number was packaged on packaging line 11 from december 27, 2016 thru december 28, 2016.Per review of the dhr¿s it was concluded that 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 samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Qn / sap database review: no.Reason: a review of the qn/sap database is not required for a s2 ¿ o1 level a investigation per cpr ¿ 071 visual analysis observations and testing: received one unused iag/bc 16ga unit in partially opened package from the lot number; 6349926.Visual/microscopic examination: the package was 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.This characteristic was met.In addition, the paper top web of the returned unit was analyzed under uv light.The glue used to seal the top and bottom webs is uv fluorescent.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 variables were looked at during the investigation.Investigation samples(s) meet manufacturing specifications: yes; the returned unit provided for evaluation for this incident met the manufacturing specification requirements in regard to package seal integrity poor/questionable.Conclusions: the defect package seal integrity poor/questionable, as stated as the reported coded was confirmed with the returned unit.Even though the package came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found.Investigation conclusion: root cause relationship of device to the reported incident: indeterminate comment: package seal integrity: 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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