H.6.Investigation summary: device/batch history record review findings: the lot number was built on afa line 9 from nov 21, 2016 thru nov 23, 2017 and packaged on packaging line 11 from nov 26, 2016 to nov 27, 2016.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.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 1 insyte autoguard bc 18ga unit from lot number 6321514.Exp.2019-10-31.Visual/microscopic examination: the package received revealed the top web (paper) was slightly lifted from the bottom web (clear) but the seal integrity was not compromised note: the product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.Conclusions: even though the package received revealed the top web (paper) was slightly lifted from the bottom web (clear) but the seal integrity was not compromised.Although the defect experienced by the customer was not confirmed with this particular incident, the failure is a known issue and was investigated under capa 48637.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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