Device evaluated by manufacturer: the product was returned inside the sealed sterile pouch.Visual examination confirmed moisture was adhered to the inside of the sterile pouch.Further examination confirmed that the moisture was silicone oil.Silicone oil was also observed surrounding the hemostatic valve.Silicone oil is used during the manufacturing process and applied to the hemostatic valve.The oil facilitates smooth operation of the valve during use.The amount of silicone oil applied to the hemostatic valve is minimal, but not constant.If manufacturing personnel determines that excess silicone oil has been applied during the set-up of the sheath and dilator, or if silicone oil deposits are observed in areas that come into contact with the sterilization bag before the product is placed in the sterilization bag, the manufacturing procedure requires to wipe off the silicone oil deposits.In addition, final visual inspection of foreign material is conducted at the package to shelf carton.It is thought that the silicone oil applied to the sheath valve came into contact with the inner sterile pouch due to vibration during transportation and storage condition.
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