Investigation - evaluation: a review of the functional test, complaint history, device history record, review of drawings, review of manufacturing, review of quality control, review of specifications, and visual inspection of the returned device was conducted during the investigation.Clinical assessment: the pilot tube is used to inflate or deflate the cuff and stays outside of the body.A leaking pilot tube would prevent the cuff from remaining inflated.An underinflated cuff could cause aspiration of subglottic secretions causing lung infections and resulting in severe harm.At this time, the clinical assessment cannot eliminate any possible causes for this event such as product handling, device preparation, securing of device, patient mobility, device failure, or manufacturing related causes.The device was returned for evaluation.A functional test was performed and no leaks were noted in the device.However a video recording was provided that proves the occurrence.A document-based investigation was performed.There is no evidence to suggest the product was not made to specifications.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed this complaint to be the only one associated with complaint lot number 8326398.Ifu states: warnings: cuff pressures should be monitored and adjusted routinely, and should never exceed 25mm hg.Over-inflation of the cuff may inhibit ventilation and may result in permanent damage to the trachea.Underinflation of the cuff may result in aspiration of subglottic secretions leading to lung infections.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.During tube preparation, ¿test the cuff and inflation system for leakage.¿ ¿simple precautions in handling of this tube during insertion and while in place will facilitate proper function and minimize tears and breaks in the inflation system.Avoid pulling or manipulation of the inflation line, as it is designed to conduct and hold air as part of the cuff inflation system.It is recommended that the inflation line be maintained in a position allowing for patient mobility without placing tension on the line-to-cannula junction.¿ based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the quality engineering risk assessment no further action is required.
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