Information was received indicating that three days following placement of a smiths medical portex bivona ¿ tts¿ tracheostomy tube, a cut was noted to the pilot line.Subsequently, it was required to perform an emergent tracheostomy (trach) change.There were no reported adverse effects.
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One custom tracheostomy tube was received for device evaluation.Visual inspection revealed a cut / tear at the pilot line, apparently caused by a sharp edge.There was no evidence to suggest excess tensile force or stretching of the pilot line.Custom devices are 200 percent inspected prior to packaging and release for distribution.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
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