Devices returned: one (1) used 011-46107-16 partial segment; one (1) pkgd.011-46107-16 monitoring kit; lot # 3112146, one (1) pkgd.A-line 1cc syringe, one (1) pkgd.Bd 10ml syringe and one (1) pkgd.A 1ml tuberculin syringe.Engineering analysis: visual analysis of the "as-received" partial segment recorded the stopcock (needleless) valve was depressed/recessed position.There were no abnormalities/damages with the returned same lot sample.Performance testing with the same lot samples and mating/access devices recorded no failures/performance issues.The engineering report documents although not always repeatable, previous engineering analysis of these valve components have shown recessed/leakage condition can potentially occur if the valve component is activated with a long luer or a luer with sharp edges at an angled entry.For optimal performance it is recommended to use connector devices that comply with iso 594-1 std.And techniques that employ a rotational motion while connecting and disconnecting the mating device to the valve as well as ensuring that the central axis of the connector and valve are inline with each other when connecting and disconnecting and not at an angle.
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Int'l.((b)(6)) complaint received reporting leakage issues with use of 011-46107-16 single line transpac iv monitoring kit w/03 ml squeeze flush, safeset reservoir and 3 needleless valves.The initial information received reports the 011-46107-16 "needleless valve fails to perform as expected.After only a few luer and slip-tip syringe accesses, the valve leaks necessitating an undesirable amount of line changes." there were no reported patient injuries, no changes in baseline status and or adverse consequences.Additional information although requested was not available.
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