H10: the device was received, for evaluation contaminated with a cytotoxic solution.Visual inspection was performed using the naked eye, which observed, a crack on the inlet.The reported condition was verified.The cause of the condition could not be determined.Due to the nature of the returned sample, no additional testing could be performed.A batch review was conducted, and there were no deviations found related to this reported condition ,during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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