In regard to this complaint, one disposable eva vgpc input set was received for investigation.As received, the tubing had been removed from its original packaging.During thorough visual inspection, no foreign material was found in the drip chamber or in the tubing itself.Device history record review revealed, no deviations and a database search showed, that no similar complaints have been reported on this specific lot previously.Based on the investigation performed, the reported failure could not be confirmed, for the returned product.The risk identified is included in the risk management documentation.Trend analysis indicates, that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.
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