Investigation: the customer reported that they noticed a hole in the blue wrap of an express ii single drain (p/n 4000-100n).They stated that they noticed it before opening the drain.No pictures were provided, but the device was returned.Upon receipt of the drain back at atrium, it was found that the tyvek pouch was torn open at the top of the drain and it is not known if the customer removed it from the pouch.No hole was identified in the csr wrap, but on the bottom right corner of the drain the wrap was not fully tucked, leaving a small gap between layers of the wrap.The drain itself was not visible through this gap.The dhr was reviewed and found no nonconformities or anomalies in its manufacturing or incoming inspection.Incoming inspection record ir481947 was reviewed and the lot of csr wrap met all material requirements, including dimensional requirements.Mp009267 (csr wrapping & pouch labeling/insertion) was reviewed which includes instructions for wrapping the drains and for identifying defects and the gap in the csr wrap which caused this complaint is not nonconforming to those instructions.The finished good specification was reviewed which also revealed that the gap in the csr wrap is not in violation of the device specifications.The ifu instructs the user not to use the drain if the device or packaging is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.A complaint history review was completed which found no related complaints.A recurring lot number report was completed which found no additional complaints against lot 483534.A review of cars/capas found no related cars or capas.A review of scars and ncrs found no scars or ncrs related to this complaint.This complaint is confirmed because of the gap in the csr wrap of the returned device.This gap is not nonconforming so a device nonconformity is not confirmed.The root-cause is customer preference issue.
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