The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the photo, it was observed that the stopcock was disconnected from the drain bag.This component is provided by a baxter supplier.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 condition was determined to be related to the supplier manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.
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