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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 338960
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2022
Event Type  malfunction  
Manufacturer Narrative
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 while using the bd facscanto¿ ii flow cytometer that there was a broken fluidics cart.The following information was provided by the initial reporter: coupling broken fluidicscart left side sheath tubing.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2022-00347 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
 
Event Description
It was reported that while using the bd facscanto¿ ii flow cytometer that there was a broken fluidics cart.The following information was provided by the initial reporter: coupling broken fluidicscart left side sheath tubing.
 
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Brand Name
BD FACSCANTO¿ II FLOW CYTOMETER
Type of Device
COUNTER, DIFFERENTIAL CELL
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15801185
MDR Text Key305806108
Report Number2916837-2022-00347
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903389605
UDI-Public00382903389605
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/13/2023
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 Model Number338960
Device Catalogue Number338960
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/07/2022
Initial Date FDA Received11/15/2022
Supplement Dates Manufacturer Received11/07/2022
Supplement Dates FDA Received02/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2013
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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