(b)(4).Five pictures of catalog number 311403 were received for analysis.They were visually inspected but the pictures are not clear enough to identify any issue that can lead to this defect.It is necessary to have the sample to perform an investigation.The device history record of batch number 74g1401830 that belongs to catalog number 311403 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to specifications.The reported complaint could not be confirmed based only on the information provided.The pictures are not clear enough to identify any issue that can lead to this defect.However, (b)(4) samples of current production (part number (b)(4) - breath circ, ane, adult, exp 0.5-1.8m w/ex) were reviewed and inspected for cracks in the extension tube and no issues were found that can lead to the condition reported by the customer.If device sample becomes available at a later date this complaint will be re-opened.
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