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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS CALIBUR¿

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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS CALIBUR¿ Back to Search Results
Catalog Number 343023
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It has been reported that the bd facs calibur¿ has been found leaking uncontained waste fluid.The following has been provided by the initial reporter: please confirm the safety check below.Was the leak fluid or air? fluid.Was the leak contained within the instrument? no.Was there spray of fluid under pressure? no.What was the fluid that leaked? non biohazard.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination or bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.Liquid is leaking from below between the sheath tank and the waste liquid tank.When the flow is set to m or h, liquid leaks from around the flow cell.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.It was determined the leakage was non-biohazard, therefore this is not considered to be a reportable malfunction.
 
Event Description
It has been reported that the bd facs calibur¿ has been found leaking uncontained waste fluid.The following has been provided by the initial reporter: please confirm the safety check below.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? no.4.What was the fluid that leaked? non biohazard.5.Did biohazard leak before or after waste line? after waste line.6.Was the waste mixed with decontamination or bleach? no.7.Was the customer/bd personnel physically in contact with the fluid? no.Liquid is leaking from below between the sheath tank and the waste liquid tank.When the flow is set to m or h, liquid leaks from around the flow cell.
 
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Brand Name
BD FACS CALIBUR¿
Type of Device
NA
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 Key14890171
MDR Text Key300441856
Report Number2916837-2022-00169
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/04/2022
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 Number343023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2022
Initial Date FDA Received07/01/2022
Supplement Dates Manufacturer Received10/04/2022
Supplement Dates FDA Received10/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2017
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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