The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 25-apr-2022.H6: investigation summary: one photo and three unit packs have been provided to our quality team for investigation.After visual inspection of both the photographs and physical samples, it was observed that the peel tab of the package was sealed, preventing proper opening of the package.A device history review was performed for reported lot 2201009, no deviations or non-conformances related to this issue were identified during the manufacturing process.Packaging parameters are set and validated according to procedure.Product undergoes testing and inspections throughout manufacturing, all results were reviewed for lot 2201009 and verified machine and packaging parameters were within required limits, and results of the of the peel tab inspection was acceptable.While we cannot identify a direct issue, this incident can occur due to an error in the packaging machine causing the cross cutting blades to move and cut in the incorrect location, resulting in the peel tab remaining sealed.
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