Additional information was added to d9, h3, h4, h6, and h10: h4: the lot was manufactured between june 28, 2023 ¿ june 30, 2023.H10: two devices were received for evaluation.Visual inspection of both devices via the naked eye was performed, and fluid inside the housing was observed which suggested a leak had occurred.The sets underwent leak testing, and a leak was observed originating from one side of the bladder crimp of both units.The reported condition was verified.The cause of the leak was determined to be due to a variation within the raw material properties and process parameters during manufacturing.A nonconformance has been opened to address this issue.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.
|