The event involved a spinning spiros® closed male luer, red cap where the spiros disconnected from back of the spiros where the luer lock is inserted on a pca tubing, with a fixed collar.There was unspecified blood loss reported, not enough to warrant a transfusion, but enough to be concerning, as the patient was a bone marrow transplant (bmt) patient with a low hemoglobin and heightened infection risk.There was also a spill of an unspecified hazardous drug, but it was reported to be a small amount since patient was on a continuous, and slow hazardous drug infusion.There was patient involvement, and no patient harm.
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No product samples were returned for investigation, however, a photograph was provided and evaluated.The photo shows two package labels of spiros from lots 4962306 and 4969219.No damage or anomalies are visible in the image.The device history review for lot number 4962306 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint cannot be confirmed based on the information provided.
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