Two stopcock bodies and one stopcock plug were returned for investigation.The customer reported that five devices contributed to five reported events (one device per event).It could not be determined which returned device was associated with which reported occurrence; therefore, the evaluation of the returned devices will be used for this medwatch.A review of the device history record, for the relevant lot, found no dimensional or functional issues for the body or the assembly.Visual inspection found that the returned stopcock bodies were both a number 8 and the returned stopcock plug was a number 10.Further inspection revealed that the stop on the stopcock plug and the tabs of the bodies were damaged.The damage observed was consistent with the stop being violated and the handle being turned in a direction not intended based on its design.During functional testing, one of the returned stopcock bodies and the returned plug were re-assembled and the force required to dissemble the device was measured; three separate trials were conducted.The force required to disassemble the stopcock body and plug, for all three trials, was found to be within manufacturing specification.The additional returned stopcock body was inserted with three new plugs, heat conditioned (to simulate sterilization) and then the force required to disassemble the stopcocks was measured; all three trials were found to be within specification.No fault was found with the returned devices based upon the re-assembly functional testing.Investigation determined the root cause of the valve popping off was due to misuse of the device.(b)(4).
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