Investigation summary: a sample was received for the purpose of our investigation.A device history report was conducted for lot number 8107025, and no related abnormalities were found.This lot of intima ii was manufactured in july of 2018; bd engineers have noted a trend in leakage for this lot.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or visual inspections.Investigation conclusion: the investigators were able to observe the reported failure mode in the sample provided.A small cracked was found during leakage testing and was located on the adapter.The returned product's parameters for swage dimension and swage length were tested and found to be within product specifications.Root cause description: depending on pressure variance in the auto line's swage pressure, it is possible for the machine to become misaligned allowing for the resulting crack to form in the device.Bd is currently conducting a long term study to determine the root cause for this event.Rationale: bd will continue to track and trend for this issue.Capa # 642738 has been initiated to address this issue.
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