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Catalog Number 334079 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/11/2020 |
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 that while using facsaria¿ flow cytometer sheath under pressure sprayed outside of instrument into the users face, but not in eyes.User rinsed face and eyes with water.There was no patient impact.The following information was provided by the initial reporter: leakage from the sheath filter, sprayed and put on the customer's face.Was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was there spray of fluid under pressure? yes.Was the customer/bd personnel physically in contact with the fluid? yes.Which part of the body was in contact to the fluid? user's face.What personal protective equipment (ppe) was being worn? no face shield and goggles.Was there any impact to patient samples due to leak? no.Was customer harmed/injured? no, flow liquid sprayed on the user's face, but not in the user's eyes.Immediately the user washed her face and eyes with running water.What is the current medical status? none.
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Manufacturer Narrative
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After further review mfr# 2916837-2020-00280 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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Event Description
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It was reported that while using facsaria¿ flow cytometer sheath under pressure sprayed outside of instrument into the users face, but not in eyes.User rinsed face and eyes with water.There was no patient impact.The following information was provided by the initial reporter: leakage from the sheath filter, sprayed and put on the customer's face 1.Was the leak fluid or air? fluid 2.Was the leak contained within the instrument? no 3.Was there spray of fluid under pressure? yes 7.Was the customer/bd personnel physically in contact with the fluid? yes 8.Which part of the body was in contact to the fluid? user's face.9.What personal protective equipment (ppe) was being worn? no face shield and goggles 10.Was there any impact to patient samples due to leak? no 11.Was customer harmed/injured? no, flow liquid sprayed on the user's face, but not in the user's eyes.Immediately the user washed her face and eyes with running water.12.What is the current medical status? none.
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Search Alerts/Recalls
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