The hith kit (inshith) was returned for evaluation: device history record (dhr) - a dhr review was performed, and no related issue was found.Failure analysis - upon investigation, photographs were taken of the returned product for further analysis.The white box of a cranial access kit was contaminated with water.The water has not penetrated through the foam into the sterile pouch inside the white cardboard box, but it is an unacceptable cosmetic defect that would erode the customer's confidence in the cleanliness and safety of the product.Excessive water contamination could absolutely breach the sterile barrier and introduce bacteria.The failure was caused by the shipping process providing inadequate protection from severe storms.Root cause - the product was damaged by the carrier after leaving this site.Dhrs were reviewed and warehouse inspected to confirm no potential source of water contamination was present or identifiable as having been a past source of water contamination.There was no adverse trend identified while conducting the investigation and trend analysis.Therefore, no corrective action is required at this time.
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