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 corrupted tubing (b)(4) (corrugated tubing, 15 x 22 mm, 60) as is described on the complaint description, this component is purchased from globalmed 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 conformances 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 was 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 is 100% tested at production line on tp-0145 (leak test).However, the current inventory that is in nl facility 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 describe on this customer description, and no issue were detected.A notification of customer complaint was sent to the supplier of this component (globalmed).
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