Initial mdr submission with device evaluation.The customer reported the male end of port broke, and returned one sample of material 20038e, lot unknown.Visual inspection verified the luer crack on the sample, and the issue of component damage.The luer collar was completely off the rest of the luer, and had whitened plastic, cracks, and a chunk out of half of the top.Previous similar investigations have found that if the application of alcohol to either mating component was not allowed proper time to dry prior to connection, there was a higher chance of luer damage.Please allow around 30 seconds after alcohol wipe for dry time.A device history record review could not be performed on material 20038e because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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