Based on supplier investigation, the device history record, lot# 20190717-23-sh was manufactured on 25th jul 2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.205g / 10 pieces.No sample was returned to the supplier at the time of the investigation, only a photo with little blue lint on the white gauze was provided.According to the manufacturer, the or towel is made of cotton, so lint is born and inevitable.The intended use of or towel is used for applying medication or absorbing small amounts of body fluids from a patient's body surface.The manufacturer will continue to work with cardinal health to better control the linting and they have implemented several measures to improve it: the suction process was added before products' final folding and operators do it according to standard operation procedure requirements.Linting test method and acceptable criteria was stipulated to see the suction results (=0.38g/10 pieces).In the folding process, the manufacturer used one cloth bag protect 100 pieces semi-finished products to avoid linting stuck onto the products during products' transfer.From the investigation, no abnormal situation happened in production and all linting test data were within the acceptable range.Therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors within the manufacturing facility for their awareness and we will continue to monitor for this type of incident.
|