Catalog Number 650686 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Common device name: automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.Medical device expiration date: unknown.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 that while using bd facs¿ sample prep assistant waste leakage occurred outside of instrument.There was no impact to patient, or user.The following information was provided by the initial reporter: it was reported that the wash station is overflowing.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Leak (if yes explain)? no.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? no.What was the fluid that leaked? unknown.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontaminate/bleach? no.Was the customer/ bd personnel physically in contact with the fluid? no.
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Event Description
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It was reported that while using bd facs¿ sample prep assistant waste leakage occurred outside of instrument.There was no impact to patient or user.The following information was provided by the initial reporter: it was reported that the wash station is overflowing.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Leak (if yes explain)? no.1.Was the leak liquid or air? liquid.2.Was the leak contained within the instrument? not contained.3.Was there spray of fluid under pressure? no.4.What was the fluid that leaked? unknown.5.Did biohazard leak before or after waste line? before waste line.6.Was the waste mixed with decontaminate/bleach? no.7.Was the customer/ bd personnel physically in contact with the fluid? no.
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Manufacturer Narrative
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After further review mfr#2916837-2020-00279 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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