(b)(4).There were no samples returned for this complaint therefore the samples returned from a similar defect from a previous complaint was reviewed.There were five pieces of actual samples returned.The complaint reported that the trac vent's connector does not fit well to the tracheostomy tube.Based on the returned samples provided, 15mm plug gauge test was conducted on the connector of the samples.The connector side is in the specification according to iso 5356-1-2015.In current manufacturing procedure, iqc department will conduct sampling gauge test before release of the part item to production.In production, 100% visual inspection at the assembly area is conducted.Any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.The incident happened may have been due to the defect on the tracheostomy tube.Further study could not be conducted since the tracheostomy tube was not return for investigation.In conclusion, the complaint reported that the trac vent's connector does not fit well to the tracheostomy tube.But as per gauge test condu cted on the returned samples, the connector met the specification.Hence, this complaint could not be confirmed.
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