Additional information: d9, h3, h4, h6 and h10.Correction to d4: expiration date: update to ni.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed where the spike was inserted into a saline bag with methylene blue, and the flow of liquid was confirmed.The permeability of the ¿y connector¿ was verified using an in-lab syringe.The reported condition was not verified.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.
|