(b)(4).The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The et tube and stylet were both returned out of their original packaging.Both double swivel connectors (tracheal and bronchial) and the y connector were returned in their original packaging.The et tube was visually examined with and without magnification.Visual examination of the returned sample revealed that the et tube appears typical.No defects or anomalies were observed.A functional inspection was performed to attempt to inflate and deflate the balloon cuffs on the returned et tube.A syringe was filled with air and attached to the valve of the tracheal (white) pilot balloon.Upon injection of air, both the pilot balloon and cuff immediately inflated.The same process was used to test the bronchial (blue) inflation line.Once again, both the pilot balloon and cuff immediately inflated.The syringe was then removed and the cuffs and pilot balloons were inspected for leaks.No leaks were detected.The syringe was then reattached in order to deflate the balloons.All pilot balloons and balloon cuffs were able to deflate.The et tube was submerged underwater and an attempt to inflate the balloon cuffs was made in order to detect any leaks.Upon injection of air, no leaks were detected.No functional issues were found with the returned sample.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "the cuff inflation system (cuffs, pilot balloons , valves) should be checked by inflation and deflation prior to use.If cuff is damaged, the tube should not be used.Care should be taken to avoid damaging the cuffs during intubation.If any one of the cuffs is damaged, the tube should not be used." "cuff pressure should be monitored routinely to assure that an adequate seal is maintained and that the cuffs have not become over-inflated." "deflate all cuffs prior to repositioning the tube.Movement of the tube with cuffs inflated could result in patient injury or in damage to the cuffs, requiring a tube change.Verify the position of the tube after each repositioning." the reported complaint could not be confirmed based upon the sample received.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.No functional issues were found with the returned device.
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