Investigation summary: samples received for investigation; upon visual inspection it can be observed the devices inside its original packaging.Small dots can be seen in the bottom web of the blister.A device history review was performed for the reported lot 2004264, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Additionally, ten retained samples were observed at the microscope, no damage or defects observed.Materials used for packaging are a film bottom web and a porous paper top web.During packaging process, the film bottom web is thermoformed with heat pressure and vacuum to give it the shape to locate the syringe.The dots noticed by customer are produced by the packaging machine when the vacuum is produced.This process has a validated process parameter window which assures the sterility of the product.Process packaging parameters were reviewed and all of them were found to be within validated process parameters.Paper used in the blisters of this catalog number is design to meet porosity requirements to ensure a correct product sterilization.Air perceived by customer may be caused due to this paper porosity.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on our investigation and given the device records did not identify any failures related to this incident, we are not able to determine a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.H3 other text : see h10.
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