It was reported a versatube¿ tapered tracheostomy tube was found to have an air leak on the distal point of the pilot tube after it was inserted into the patient.A second like device was used, (associated medwatch 1820334-2018-00936), and the same issue was observed.The procedure was completed using a third device.
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Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), trends, quality control, 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 not returned however a provided video recording proves the occurrence.Additionally, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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 there was no other complaint associated with this complaint lot.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, no product returned, and the results of our investigation, a definitive root cause could not be determined.
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