It was reported that a clearlink, paclitaxel set leaked from "one of the splices" (pump segment/bushing); there was a small opening in the spliced area.This was identified during patient infusion with taxol on an unspecified pump.The issue was further described as, "the taxol starting spraying out of the spliced area above the clamp" and the pumped alarmed an air in line alarm.A new set was used to continue treatment and a spill kit used to clean up the leak.The nurse was exposed to the medication on their hands; however, the nurse washed their hands with no further issues noted.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Additional information was added to d4, h3, h4, and h6.The actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The components are correctly placed and according to specifications.Functional testing included pressure testing, clear passage underwater testing, priming, and pull testing, and no defects were observed that could generate a leak.The reported condition was not verified.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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