Product complaint # (b)(4).Date sent to the fda: 8/11/2020.Additional information: d10 correction: d2, d2b, g5.H3 evaluation: received one used 15fr drain, attached to the adapter.We inspected the drain visually, but no non-conformities were detected.Then we inspected the drain functionally, while its fluted part was immersed into a bowl filled with water.The drain was attached to the reservoir 100cc, and negative pressure was applied.The reservoir held the pressure properly and the drain functioned normally.There was no non-conformity detected in the received sample of the drain.The complaint is not verified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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