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A review of the returned chest drain was conducted to determine if a hair had been inadvertently shipped within the product packaging.Upon removing the chest drain from the shipping box it was clear that the original packaging had been completely opened including the sealed pouch.In this regard determining where or when the hair was introduced is impossible to define.Upon reviewing the entire packaging closely.A hair could not be found.The drain was carefully lifted from the packaging and both the drain and packaging was again inspected for a hair.No hair was found.The drain was lifted carefully from the tyvek pouch and the individual drain and pouch were again inspected.No hair was found.As a hair cold not be found the complaint cannot be confirmed.It is possible that the hair was introduced when the pouch was opened.A review of the device history records shows that this lot of chest drains passed all quality requirements and there were no non conformances noted during the manufacture of the drain.During the manufacture of the product there are multiple steps to ensure the cleanliness of the product prior to and during the packaging process.Prior to placing the assembled drain in the packaging tray per procedure.Each drain is inspected for particulate and hair is not allowed per the procedure.Every drain is then hand wrapped by a production operator who inspects the blue csr wrap that the drain is wrapped in.Per production procedure, each blue wrap is inspected for foreign matter prior to being placed on the drain: "inspect the csr wrap for uniform color (blue), tears, grease, pinholes and particulate".This is conducted prior to placing the drain into the pouch.Based on the investigation atrium medical corporation cannot conclude that a hair was present in the package.There is a possibility that when the pouch was opened at the institution a hair fell on to the drain however no hair was found on the returned drain.All chest drains are manufactured and packaged within a clean room environment where all efforts are made to ensure that the chest drains are clean and free of loose fibers or hairs.The procedure for gowning prior to entering the clean room requires all staff members to be suited in a one piece full body gown with two separate bouffant caps that cover all hair and beard covers if required and full foot coverage booties.All manufacturing personnel are trained on proper gowning technique.
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