Investigation summary: one photo was submitted for quality investigation.The customer complaint of component damage - leak, the failure reported could not be verified.The tubing does appear to be kinked at the location indicated in the picture, however, it cannot be determined if this kink can be massaged out due to the physical sample not being submitted.A device history record review for the model and lot number was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no physical sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported y ext w/vlv ports & 2 sld clp had kinked tubing and leaked.The following information was provided by the initial reporter: "plastic tubing was damaged prior to use, the tubing appears crimped or possibly melted and there was a hole in so when the rn placed on her iv site and tried to draw from it, blood came out the extension tubing instead of in to the lab tube.".
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