It was reported that, during use, the connector of a prismaflex m150 set ckt was found broken, leading to a leak of saline solution.The reporter stated that the male luer connector remained stuck in the female luer connector of the effluent bag after disconnection.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Additional information: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed that the cone of the male luer connector of the effluent line was cracked.The reported condition was verified.The cause of the condition was not determined.Additional recommended instruction is provided with this device for how to connect the female luer lock and the male luer.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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