Udi (b)(4).The product sample was received for evaluation and stain on pattie was confirmed.There was also a burn mark present with staining around the green string.Device history records (dhrs) were reviewed and no anomalies were found.The cottonoid is formed from a rayon material.During processing, rayon material is broken down into small fibers.If the fibers are not properly broken down, a small cluster of fibers can result.This creates a thick spot in the pattie.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Patties created on the hybrid machines are visually inspected during the operator before being carded.Operators fan through the stack of 10 patties counting each pattie and ensuring there are no defects.They then flip over the stack and repeat before attaching the stack to a card.Because the burn mark was missed the complaint can be attributed to operator error.Training was opened to retrain the operator.Based on the results of the investigation, the reported issue was confirmed.Trends will be monitored for this or similar complaints.
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