Investigation summary: a device history review was conducted for lot number 7346995.Our records show the reported lot was manufactured on august 28, 2018, and determined that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections of packaged goods.The device and photographs provided by the facility were evaluated.Our examination was unable to find any evidence of leakage in the unit provided, however the loose cap could be confirmed through observation of the photographs.Loosened caps are a known issue, and often occur during transit.Because this occurs after the device has left our facility, our instructions for use recommend that the caps be tighten prior to use of any nexiva product.Bd will continue to track and trend for this issue.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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