From the device history record, lot#20200403-23-sh was finished on 06th may 2020 and lot#20191227-23-sh was finished on 26th dec 2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data are 0.167g/(b)(4) and 0.171g/10pcs.No sample was available for investigation, only photos were provided.There is blue lint found on the surface of the instrument and there is no lint on the surface of the towel.According to supplier, operating room 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: suctions 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 requirement, linting test method and acceptable criteria was stipulated to see the suction results.(b)(6), in the folding process, supplier used one cloth pad under (b)(4) semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, no abnormal situation happened in production or dhr.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
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