(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the airway tube looked slightly yellowish due to multiple uses.The check valve was inspected and found to be functioning.No blockage was detected.The device was then inflated with 1x recommended air volume and no herniation was visible on the cuff.When the device was inflated with 1.5x the recommended air volume, it was noticed that there was a herniation 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.The manufacturer of the device states that high temperature, vacuum, and humid autoclaving environment, and air/moisture left inside the cuff will expand significantly and it will damage the properties of the device to an irreparable condition.It is suspected that some residual air/moisture was left inside the device while handling/reprocessing.The cuff must be completely deflated prior to autoclaving.
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