Two (2) pictures of a section of the product catalog number 313901 (breathing circuit, anes, ped, 1.5m w/ext h) were received for analysis.They were visually inspected finding a crack in the corrugated tubing (b)(4) (corrugated tubing, 15x 22 mm, 60) as is described on the complaint description, this component is purchased from (b)(4) supplier.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number (b)(4) has been reviewed and no issues or discrepancies were found related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specs.The customer complaint aas confirmed based on the visual inspection of the received pictures, because it was detected a crack on the corrugated tubing (b)(4) (corrugated tubing, 15 x 22 mm, 60), at present time it is not possible to determine where the issue reported occurred, since this condition if 100% tested at production line on tp-0145 (leak test).However the current inventory that is in nl factory of (b)(4) (corrugated tubing, 15 x 22 mm, 60) related to this complaint notification was inspected by the defect of "cracks" as it is described on this customer description, and no issues were detected.A notification of customer complaint was sent to the supplier of this component ((b)(4)).
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