Initial reporter phone #: (b)(6).Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 1350193.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 and encourages you to submit your sample for review.
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It was reported by the customer that the bd intima-ii¿ closed iv catheter system was loose.The following information was provided by the initial reporter, translated from chinese to english: the indwelling needle prn loosens, causing fluid and blood to leak into the patient and sheets.
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