Supplemental report is being filed following the submission of the initial mdr report that was submitted on 9/19/2022, due to the investigation findings are available.From the device history record, lot #20220128-23-sh was finished on march 22, 2022.No exception was recorded in the device history record (dhr) that could lead to the reported incident.The average linting data is 0.128g/10pcs.A sample was not available for investigation.Photo was provided which showed blue lint on the guide wire.According to the supplier, the or towel is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suction machines have been installed in grey cloth rolling process, dyeing process and cutting process, the suction process was added before product's final folding, and workers do it according to standard operation procedure (sop) requirement, linting test method and acceptable criteria was stipulated to see the suction results at (=0.38g/10pieces), and in the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting sticking onto the products during product's transfer.From the investigation, no abnormal situation happened in production or device history record.Therefore, the root cause could not be determined.Cardinal will continue to monitor complaint trends for this product.
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