E1: initial reporter address: (b)(6).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, d9, h3, h4, h6, h11.H11: two (2) actual devices were received for evaluation.A visual inspection was performed, and it was noted that there was a cut in the tubing.Pressure testing and clear passage under water testing were performed, and it was noted that there were leaks from the hole/cut in the tubing.Special tests included connecting an 8-psi air source to the tubing and thirty (30) times clamp activation in the same location, and no issues were noted.The reported condition was verified.The cause of the reported condition could not be 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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