(b)(4).Four pieces of representative sample were received.The samples were closely examined by visual inspection.Complaint reported that the tracheostomy tube does not fit into the teleflex trach-vent ref 41312.It's too difficult to attach without injuring the patient.Based on the returned samples provided, 15mm plug gauge test was conducted on the connector of the samples.The connector side is in specification.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, 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 may have happened due to the defect on tracheostomy tube.Further study could not be conducted since the tracheostomy tube did not return for investigation.Complaint reported that tracheostomy tube does not fit into the teleflex trach-vent ref 41312.But as per gauge test conducted on returned samples, the connector met the specification.Hence, this complaint could not be confirmed.
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