A device history review was conducted for lot number 8037509.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 in packaging visual inspections.A sample could not be obtained.Previous investigations have found that the leakage between the housing and tap are caused by worn components in the manufacturing machinery.When worn down, these components can lead to an improper connection between the valve housing and the tubing of the device, causing a leak to occur at this junction.To prevent the reoccurrence of this event, the worn component was replaced on (b)(6) 2018.Bd will continue to track and trend for this issued for this issue.Nogales will open a capa (b)(4) not because of the cid as it is ¿no capa required¿ as per (b)(4) based on the severity and occurrence calculation, the reason to open the capa is to better support the exposure to external stakeholders, the focus of the capa will be batch 8037509 and sub-assembly lots related to that batch.
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