The returned device was opened and inspected for damage.There was no visible damage noted of the tyvek/nylon pouch.The drain was removed from the pouch and the csr wrap was removed from the drain.The csr wrap had an area marked with a circle indicating the slit in the wrap.Both wraps were noted to have the same slit in the same area.During the inspection the wedge tray that the drain is placed into was noted to be crushed on one corner.The slits in the wrap correspond to the opposite corner of the wedged tray.Oasis drains are packaged following manufacturing procedures and each piece of csr wrap is inspected for damage including, but not limited to, tears and pinholes.A device history record review was performed and the drain lot was found to have met all specifications.The cause of the slits in the csr wrap appear to be attributed to damage during shipping or handling of the unit.The handling and distribution simulation testing, which was conducted for this product line, is intended to subject products to conditions they may typically encounter in their distribution cycle.The testing is not inclusive of every event that may occur to a product during distribution.Clinical evaluation: a package that is damaged would be noticed prior to admission to a sterile field.
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