(b)(4).The device was received and evaluated.Visual inspection found that the membrane tube was torn off and the hanger hole damaged.In addition, there were external markings on the port tip consistent with an external force.The reported condition was verified.The cause of the condition was not determined.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.
|