D4: the lot # is dr20k14039, previously submitted as asku.D4: the udi # is (b)(4), previously submitted as ni.H10: the device was received for evaluation.A visual inspection was performed using the naked eye which observed a transversal cut in the tubing.The reported condition was verified.The cause of the condition was caused by the packaging machine during the manufacturing process.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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