Concomitant product - unspec needleless connector, mfr unk; unspec primary tubing, mfr unk; chemoclave bag spike, ln ch-10, lot #unk, mfr icu medical, inc.; 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap, ln ch3034, lot #unk, mfr icu medical, inc.; unspec chemotherapy, mfr unk.No product samples, videos, or photographs were returned for investigation.The device history review (dhr) for lot number 3786892 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
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The event involved a spinning spiros® closed male luer that disconnected or separated resulting in a chemotherapy spill.It was reported that the chemo bag was spiked with a chemoclave bag spike, which was connected to 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap, then connected to primary tubing with the spiros at the end attached to the needleless connector.It was reported that 15 minutes after hanging chemotherapy, the patient alerted the nurse to a disconnection in iv tubing.The inner tube of the spiros was found detached from the outer encasement.The inner tube was found connected to the iv tubing and the outer encasement of the spiros remained connected to the needleless connector.The chemo spill was cleaned as per facility protocol.The tubing was replaced, the drug replaced and therapy resumed.There was patient involvement, no patient harm, no medical intervention required.
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