(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 74j1401555 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 non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot 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, 13 samples of current production p/n 311403 (breath circ, anes,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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