H10: the actual device and a photograph of the device were received for evaluation.The returned photograph was reviewed, and it was noted that the tubing was separated from the y-connector.A visual inspection was performed on the actual sample, and it was noted that there was no solvent residue present around the inner perimeter of the y-connector.It was also noted that the disconnected tail-end was missing and was not returned with the set (most likely since this was contaminated with blood).The reported condition was verified.The cause of the reported condition could not be determined; however, it is possible that during the assembly of this set, an incorrect amount of solvent was applied to the tube during the automated assembly, leading to a disconnection.However, as the actual sample arrived at the plant without the tail-end, it is not possible to conclude or confirmed the root cause.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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