Device manufacture date: may 9, 2016 ¿ may 11, 2016.The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection was performed and revealed that the tubing of the infusor unit has been cut.The reported condition was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
|