Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and the airway tube looks lightly yellowish due to multiple uses.The check valve was inspected and it was functioning properly.This means air can be blown in and removed from the device smoothly with a syringe and no blockage was detected.When the device was inflated with 1x the recommended air volume, no issues were detected; however, when the device was inflated with 1.5x the recommended volume of air, a herniation was observed in the cuff.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.Over-inflation is a known cause that leads to cuff herniation.
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