Catalog Number 383517 |
Device Problems
Leak/Splash (1354); Device Fell (4014)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd nexiva¿ closed iv catheter system leaked.No serious injury or medical intervention was reported.Verbatim: "material no.: 383517, batch no.: 7335675.It was reported the hubs are leaking and the blood stopper falls off.Verbatim: leaking hubs, blood stopper falls off".
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Manufacturer Narrative
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H.6.Investigation: dhr review was done found 1 non-related qn (b)(4)-incorrect labeling-pkg) where disposition of the product, root cause and corrective action were applied according to the quality control plan.All other challenges, set-up and in process samples were performed per quality control plan without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.
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Event Description
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It was reported that bd nexiva¿ closed iv catheter system leaked.No serious injury or medical intervention was reported.Verbatim: "material no.: 383517.Batch no.: 7335675.It was reported the hubs are leaking and the blood stopper falls off.Verbatim: leaking hubs, blood stopper falls off.".
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Search Alerts/Recalls
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