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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
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BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Catalog Number 443972
Device Problem Device Ingredient or Reagent Problem (2910)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd epicenter¿ single user software specimen association changing.The following information was provided by the initial reporter: customer requesting assistance with specimen association changes.Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.
 
Event Description
It was reported that bd epicenter¿ single user software specimen association changing.The following information was provided by the initial reporter: customer requesting assistance with specimen association changes.Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01435 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 EPICENTER¿ SINGLE USER SOFTWARE
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15884030
MDR Text Key307092035
Report Number1119779-2022-01435
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/03/2023
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 Catalogue Number443972
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2022
Initial Date FDA Received11/30/2022
Supplement Dates Manufacturer Received04/03/2023
Supplement Dates FDA Received04/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2017
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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