Qn# (b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was performed.And it was observed, that the airway tube of the device was yellowish.No physical damage was observed, from the outer profile of the device.Functional testing was also performed.And the cuff was able to be inflated and deflated normally with the check valve.However, it was found, that the cuff could not be deflated, when red plug was opened.A device history record review was performed.And no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The manufacturing site reports "the opening of the red plug was blocked by the valve, hence the cuff could not be deflated, even when the red plug was opened.The most probable root cause could have been, due to excessive force applied to the valve inside the blue inflation balloon.When inflating or deflating the device over the uses, the valve had sink further into the tubing.Which resulted, the red plug opening being blocked by the valve.Nonetheless, this device is still functional.And can be still deflated and inflated using the check valve".
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