The problem happened during a trial made to evaluate the device from a new user.The same problem was claimed on code# (b)(4) coaxial drain ch 24; lot#: f2003060 too.We asked for several questions in order to investigate the cause, but after 3 calls we didn't receive any answer.Consequently no investigation has been done for missing information.We don't have any similar issue on our complaint database on the lot involved and in all other lots produced, so we can presume that the device is not defective.However, in the document review, we have noted the en ifu claims that the drainage "prevent tube occlusion", due to a translation error and misinterpretation of the (b)(6) version.We will review the ifu with correct words.
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