Investigation summary: a 10011098 sample was not available for investigation; however the customer indicated the complaint sample is from lot 22026076.The feedback provided by the customer indicates leakage occurred from a damaged male luer of the smartsite stopcock device.As part of the investigation, the customer provided a photograph of their experience; analysis of the photograph confirms the customer's experience as the rotating male luer collar appears to have broken and was separated from the rest of the smartsite stopcock device.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22026076 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the damaged male luer collar could not be determined, however please note that damage of this nature can be caused or contributed to by combination of different factors, including; over-torque of the component during connection with the female luer, use of a female luer that is not compliant to iso standards, or prolonged use of substances that are aggressive to plastics.In this instance based on the information available, it has not been possible to determine which of these factors may have contributed to the customer's experience.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 10011098 product over the past 12 months.
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