(b)(6).The actual device was not available; however, photographs of the sample were provided for evaluation.The visual inspection of the provided pictures shows that there was an external blood leak at the level of the access screwed connector.The reported condition was verified.The cause of the condition could not determined.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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