As reported by the user facility: event #2 - reports two incidents of chemo spills due to leakages at the backcheck valve.Both occurred on the bone marrow transplant unit.The first incident, a small amount (< 20ml) of rituxan leaked from the reflux port.The tubing was replaced and the infusion restarted.The second incident, the nurse entered the pt room at 18:30 on (b)(6) 2014 and noticed a slow drip on the floor from the circular piece that is part of the iv piggyback tubing set.The drip was steady and continuous.The entire bag of etoposide was empty.
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This report has been identified as b braun medical inc., (b)(4).The actual device involved in the reported incident was not returned for eval.Without the actual sample, a thorough eval could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.If a physical sample is received or if add'l pertinent info becomes available, a f/u report will be filed.
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