Additional information added to h3, h6 and h10.H10: a sterile companion sample was received for investigation.Visual inspection and simulated test were performed and no issues were observed.Based on information provided by the customer, the customer connected a y accessory between the patient catheter and the luer lock of the access line.Per the instruction, the access line of the set must be directly connected to the patient catheter via the male luer connector of the access line.The use of additional devices, such as three-way valves, stopcocks, or extension lines, may impair pressure monitoring.The use of the y-connector during treatment is considered user error.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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