Upon further due diligence, "after opening the sterile outer packaging a crack/defect was detected".No leak occurred.Two devices were received for evaluation.Visual inspection was performed which observed that the tubing was kinked; however, no other damage was observed.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.
|