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According to the facility, the or towel began linting when drying hands after wet surgical hand wash/scrub, and the or towel was used to dry scrub rn¿s hands prior to case.The photos provided by the customer were reviewed, the vendor was notified of the issue, trend analysis was performed by reviewing the past two years of complaint data, the entire production process was reviewed, and retain samples were reviewed.The photos showed blue fabric lint on the hands of medical professionals after using the or towel, confirming the customer¿s issue; retain samples did not replicate the reported defect.Based on the vendor¿s internal investigation, the vendor believes that the defect was caused during the sewing process where fiber dust accumulates and forms into lint and falling onto the product due to equipment vibration, and corrective actions have been implemented.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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