Investigation summary: in response to the event reported a device history review was conducted for the provided material and lot number.Our records show 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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
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It was reported that blood and fluid seeped from the eye after the bd intima ii¿ closed iv catheter system was used on the patient, causing infection.The following information was provided by the initial reporter, translated from chinese: ".After the bd indwelling needle was replaced, blood and fluid seepage frequently occurred at the eye of the needle, and some of the eye of the needle was infected, and the service period was shortened".
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