G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
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Additional information: d4, h3, h4, h6, h10 h10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that there was a separation between the tubing and y-site clearlink.The reported condition was verified.The cause was 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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