(b)(4).One sample of catalog number 1088 mask, multi-vent, adult was received for analysis.A visual exam was performed and it was observed that the sample was not in the original packaging.No other issues were observed.The instructions for use (ifu) states that if humidification is desired, use the high humidity adaptor and connect the adaptor to the humidity source with large bore tubing, which is not supplied with the kit.The customer complaint could not be confirmed as the required components for the humidification test are not supplied with this catalog number and the received sample was not in the original packaging.Based on this, it is not possible to establish a corrective action since the customer complaint could not be confirmed.The root cause for the condition reported could not be identified.However, regarding this issue all personnel from the production line were notified.
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