This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).(udi) is unknown.No product information has been provided to date.510k is unknown.No information has been provided to date.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.One sample was received in used conditions, without its original packaging.The sample was visually inspected with a 12 inches distance under normal conditions of illumination.During the visual inspection, it was observed that the elbow was missing.The most probable root cause was during manufacturing process, the elbow was separated from the unit after the leak test because it was not assembled correctly by operator.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.
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