One smiths medical portex tt adult tracheostomy (trach) tube was returned for analysis in used condition.No discrepancies were found upon visual examination.A syringe was used to inflate the cuff and submerged under water to verify for leaks; finding no discrepancies.Relevant document were reviewed and deemed adequate.An audit of the production floor was conducted and operations were reviewed: training records, inflation line assembly operation, and cuff assembly operation.No discrepancies were found following review of operations.The inflation test was audited during thirty two (32) units revealing no deflated cuffs.Based on the evidence, no root cause has been determined since the complaint was not confirmed.
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