Additional information: d4, d9, h3, h4, h6, h10 h4: the lot was manufactured between february 14, 2023 -february 16, 2023.H10: the actual device was received for evaluation.During visual inspection the flow restrictor housing was observed damaged.The reported condition was verified.The cause of the condition could not be determined.However, indentation marks from the manufacturing flow wrap sealer equipment were observed on the damaged area of the flow restrictor housing which suggested the cause of damage may be related to manufacturing.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.
|