One portex® endotracheal tube was returned for analysis in used conditions.Visual inspection revealed excess solvent to the inflation line to the tube.The ett was inflated with a syringe in which resistance was present to inflate or deflate the cuff.Partial occlusion was noted to the assembly of the inflation line to tube.Relevant documents were reviewed and deemed adequate.Training records and inflation line assembly operation were both reviewed; no discrepancies.The bell-out, fit inflation line and leak test operations were audited on 32 units; no discrepancies observed.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing process as the most probable causes were excess solvent or lack of detection.
|