A sample was received at the investigation site without the original packaging and in used condition.Visual inspection: visual inspection was performed at 12 inches under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.Results: when inflating the sample, the cuff only inflated one side.The cuff was manipulated and the whole cuff inflated.However, extremely force was required to inflate the cuff.(teflon was not properly distributed inside the cuff).The root cause was related to manufacturing process.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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