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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD; COUNTER, DIFFERENTIAL CELL

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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 342975
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Event Description
It was reported that while using facscalibur cytometer 4 color basic ivd leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: dripping probe.The specialist replied that: 1.Is the leak fluid or air? liquid/fluid.2.Was the leak contained within the instrument? external/outside leakage of the equipment.3.Was the fluid actively spraying about outside the machine? only when the equipment was on standby.4.Is leaked liquid type known? biohazardous or non-biohazardous? saline solution used in the equipment, not biological.5.Did the leaked liquid have bleach mixed in? there was no bleach mixed.6.Was anyone injured due to the leaked liquid? there were no injured people.
 
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.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00407 was sent in error.Information regarding leak stated that the leakage was contained, therefore, this is not considered to be a reportable malfunction.
 
Event Description
It was reported that while using facscalibur cytometer 4 color basic ivd leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: dripping probe.The specialist replied that: 1.Is the leak fluid or air? liquid/fluid.2.Was the leak contained within the instrument? external/outside leakage of the equipment.3.Was the fluid actively spraying about outside the machine? only when the equipment was on standby.4.Is leaked liquid type known? biohazardous or non-biohazardous? saline solution used in the equipment, not biological.5.Did the leaked liquid have bleach mixed in? there was no bleach mixed.6.Was anyone injured due to the leaked liquid? there were no injured people.
 
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Brand Name
FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12665897
MDR Text Key284177781
Report Number2916837-2021-00407
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903429752
UDI-Public00382903429752
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K923790
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 02/02/2022
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 Model Number342975
Device Catalogue Number342975
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2021
Initial Date FDA Received10/20/2021
Supplement Dates Manufacturer Received02/02/2022
Supplement Dates FDA Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2013
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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