E1: initial reporter first name: e1: initial reporter last name: e1: initial reporter facility name: the actual device was not available; however, photographs of the sample were provided for evaluation.During visual inspection of the photos, it was observed that the access line was perforated near the screwed connector.The reported leak is due to the observed tubing perforation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the damaged tubing was not determined.Should additional relevant information become available, a supplemental report will be submitted.
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