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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT; SEE H.10
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT; SEE H.10 Back to Search Results
Catalog Number 650686
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Event Description
It was reported that bd facs¿ sample prep assistant was overflowing biohazard from the wash tower.The following information was provided by the initial reporter: "it was reported by the customer that the wash station is overflowing.Leak questions from smax checklist: was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid that leaked? unknown.Did biohazard leak before or after waste line? unknown.".
 
Manufacturer Narrative
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that bd facs¿ sample prep assistant was overflowing biohazard from the wash tower.The following information was provided by the initial reporter: "it was reported by the customer that the wash station is overflowing.Leak questions from smax checklist: was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid that leaked? unknown.Did biohazard leak before or after waste line? unknown".
 
Manufacturer Narrative
After further review, this complaint was determined to be not reportable.Leakage of fluid was contained.Leakage of fluids are unlikely to lead to a serious injury or death due to the passive nature, and is not likely to lead to contact of the user or patient.Therefore, this complaint will be cancelled.
 
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Brand Name
BD FACS¿ SAMPLE PREP ASSISTANT
Type of Device
SEE H.10
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12897761
MDR Text Key284385462
Report Number2916837-2021-00471
Device Sequence Number1
Product Code PER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2021
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 Number650686
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2021
Initial Date FDA Received11/30/2021
Supplement Dates Manufacturer Received12/08/2021
Supplement Dates FDA Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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