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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSARIA
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSARIA Back to Search Results
Catalog Number 656700N4
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that while using bd facsaria¿ waste leakage without bleach was not contained (outside instrument).There was no report of customer or patient impact.The following information was provided by the customer.After turning on the instrument and running the start-up, a drip coming from the sample line is observed.
 
Manufacturer Narrative
After further review mfr#(b)(4).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.
 
Event Description
It was reported that while using bd facsaria¿ waste leakage without bleach was not contained (outside instrument).There was no report of customer or patient impact.The following information was provided by the customer.After turning on the instrument and running the start-up, a drip coming from the sample line is observed.
 
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Brand Name
BD FACSARIA
Type of Device
NA
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
MDR Report Key11003742
MDR Text Key222022283
Report Number2916837-2020-00304
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number656700N4
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received12/14/2020
Supplement Dates Manufacturer Received06/18/2021
Supplement Dates FDA Received06/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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