Catalog Number 335221 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported while using bd facs aria¿ waste leakage occurred outside of instrument.User impact was not reported.The following information was provided by the initial reporter: it was reported that the closed loop nozzle becomes wet when instrument stream is running.Was the fluid contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? waste.What is the source of leak -- waste line or non-waste line? waste.If waste line, whether it is mixed with bleach or decontaminate? no.
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Event Description
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It was reported while using bd facs aria¿ waste leakage occurred outside of instrument.User impact was not reported.The following information was provided by the initial reporter: it was reported that the closed loop nozzle becomes wet when instrument stream is running.Was the fluid contained within the instrument? no.2.Was the leak in a customer accessible location? yes.3.What was the fluid that leaked? waste.4.What is the source of leak -- waste line or non-waste line? waste.5.If waste line, whether it is mixed with bleach or decontaminate? no.
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Manufacturer Narrative
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After further review mfr#: 2916837-2020-00330 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.
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Search Alerts/Recalls
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