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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSDUET SAMPLE PREP
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSDUET SAMPLE PREP Back to Search Results
Catalog Number 662588
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
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.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that during use with bd facsduet¿ sample prep foreign matter (black growth) was discovered inside of the di water line.There was no reported patient impact.The following information was provided by the initial reporter: 662588 - bd facsduet - black growth inside di water line from tank.
 
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 during use with bd facsduet¿ sample prep foreign matter (black growth) was discovered inside of the di water line.There was no reported patient impact.The following information was provided by the initial reporter: 662588 - bd facsduet - black growth inside di water line from tank.
 
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Brand Name
BD FACSDUET SAMPLE PREP
Type of Device
NA
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
MDR Report Key10868506
MDR Text Key247627392
Report Number2916837-2020-00266
Device Sequence Number1
Product Code PER
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 06/17/2021
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 Number662588
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received11/19/2020
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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