Initial reporter phone number: (b)(6).Initial reporter facility name: (b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture showed that the access line was perforated near the screwed connector.The reported condition was verified.The cause is manufacturing related.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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