This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed samples was received decontaminated and without its original packaging.Customer?s reported issue was duplicated.Under visual inspection it was noticed that inflation lumen on the tracheostomy tube was punctured in place where inflation line connects with the lumen.Such defect can happen once adjustable flange is over pulled above the last marking on the tube (close to 15mm connector) which conflicts with instruction for use.The root cause of the reported issue was determined.It is probable that the reported failure occurred during tracheostomy procedure by contact with sharp edge which conflicts the instruction for use.Actions taken to mitigate the reported issue: no corrective actions were taken.During manufacturing process, the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.
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