Investigation summary: in response to the event reported, a device history review was conducted for lot number 1076790.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 when using the bd intima-ii¿ closed iv catheter system, the device experienced leakage.The following information was provided by the initial reporter.The customer stated: the prn was leaked when intravenous indwelling needle was used for infusion, so it was replaced with a new indwelling needle and re-punctured before infusion.
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