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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD CYTOMETRIC BEAD ARRAY
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BECTON, DICKINSON AND CO. BD CYTOMETRIC BEAD ARRAY Back to Search Results
Catalog Number 551809
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 10/15/2020
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.(b)(4).
 
Event Description
It was reported that while using bd¿ cytometric bead array the cartridge leaked bio hazardous material.The following information was provided by the initial reporter: it was reported that there is a filter plate protocol issue and sample leak.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3007886372-2020-00003 was sent in error.The leakage was not biohazardous and therefore, is not considered to be a reportable malfunction.
 
Event Description
It was reported that while using bd¿ cytometric bead array the cartridge leaked bio hazardous material.The following information was provided by the initial reporter: it was reported that there is a filter plate protocol issue and sample leak.
 
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Brand Name
BD CYTOMETRIC BEAD ARRAY
Type of Device
NA
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
10865 road to the cure
suite no. 210
san diego CA 92121
MDR Report Key10785456
MDR Text Key225598904
Report Number3007886372-2020-00003
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2021
Device Catalogue Number551809
Device Lot Number0183093
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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