Accudrain with anti-reflux valve i(ns8401) was not returned for evaluation; therefore, an evaluation of the device could not be performed.The reported lot number 546124 is missing one (1) digit; therefore, the documentation review was performed to 5416124 (ins8401).No anomaly was observed in the reviewed records that could be related to the reported condition.Given that the device has not been returned for evaluation, root cause determination is not possible at this moment.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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