H4: the lot was manufactured april 19, 2022 to april 20, 2022.H10: the device was received for evaluation containing fluid in the bladder.Visual inspection was performed via the naked eye showed no fluid coming out of the tubing line after the slide clamp was disengaged and the blue winged luer cap was opened.After the tubing line was cut, no evidence of fluid was observed flowing out of the tubing line which indicates blockage at the junction of the tubing and stressmember located at the upper area of the device.An indentation from the clamp was observed on the tubing line, however the clamp indentation was not the cause of no flow.It is normal condition that a clamp would create an indentation on the tubing line after the clamp is closed on the tubing line.The device was disassembled for further examination under the microscope.As a result, the needle located inside the stressmember was found to be misassembled.The needle touched the tubing port which blocked the fluid path and did not allow fluid to flow out of the tubing line.The reported flow condition was verified.The cause of the flow condition was related to the assembly process during 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.
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