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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS; FLOW CTYOMETRIC REAGENTS AND ACESSORIES
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS; FLOW CTYOMETRIC REAGENTS AND ACESSORIES Back to Search Results
Model Number 335775
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2022
Event Type  malfunction  
Event Description
It was reported that while using the bd facs¿ 7-color setup beads 25 tests that the lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.The following information was provided by the initial reporter: lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Pma / 510(k)#: k040026, k141468.
 
Event Description
It was reported that while using the bd facs¿ 7-color setup beads 25 tests that the lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.The following information was provided by the initial reporter: lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2022-00356 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.
 
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Brand Name
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
Type of Device
FLOW CTYOMETRIC REAGENTS AND ACESSORIES
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 Key15870415
MDR Text Key307906692
Report Number2916837-2022-00356
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903357758
UDI-Public00382903357758
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K040026
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 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number335775
Device Catalogue Number335775
Device Lot Number85543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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