(b)(4) follow-up emdr for device evaluation: five photos were provided to our quality team for investigation.Through visual inspection of the photos indicate blue foreign matter that is larger than 0.80 square millimeters, the cut off point for flash size.The size of these particles is over the limit when checked during the tappi particle size evaluation therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001394942 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the information provided, a probable root cause is inattention to detail for this investigation.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer here.
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