Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
system, blood culturing
Regulation Description
Microbial growth monitor.
Product Code
MDB
Regulation Number
866.2560
Device Class
1
Premarket Reviews
Manufacturer
Decision
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
37
37
2021
1184
1184
2022
643
643
2023
1232
1232
2024
400
400
2025
112
112
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
1793
1793
Incorrect, Inadequate or Imprecise Result or Readings
978
978
False Negative Result
225
225
Contamination
198
198
Device Markings/Labelling Problem
121
121
Leak/Splash
86
86
Cross Reactivity
83
83
Contamination of Device Ingredient or Reagent
48
48
Microbial Contamination of Device
26
26
Unintended Movement
20
20
Missing Information
19
19
Fluid/Blood Leak
17
17
Break
15
15
Device Contamination with Chemical or Other Material
13
13
Contamination /Decontamination Problem
12
12
Fire
5
5
Data Problem
4
4
Device Ingredient or Reagent Problem
3
3
Communication or Transmission Problem
3
3
Inaccurate Information
3
3
Crack
3
3
Failure to Obtain Sample
3
3
Missing Test Results
3
3
Patient Data Problem
3
3
Product Quality Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Patient-Device Incompatibility
2
2
Device-Device Incompatibility
2
2
Material Integrity Problem
1
1
Alarm Not Visible
1
1
Unable to Obtain Readings
1
1
Failure to Power Up
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Audible Prompt/Feedback Problem
1
1
Misassembly by Users
1
1
Defective Component
1
1
Unintended Electrical Shock
1
1
Device Damaged Prior to Use
1
1
Physical Resistance/Sticking
1
1
Output Problem
1
1
Excessive Heating
1
1
Device Contamination with Body Fluid
1
1
Difficult to Open or Close
1
1
Mechanical Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanical Jam
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3491
3491
No Consequences Or Impact To Patient
123
123
Insufficient Information
36
36
No Known Impact Or Consequence To Patient
19
19
No Patient Involvement
10
10
Bacterial Infection
10
10
Misdiagnosis
6
6
Sepsis
5
5
No Information
5
5
Death
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Drug Resistant Bacterial Infection
1
1
Fungus
1
1
Fungal Infection
1
1
Crushing Injury
1
1
Local Reaction
1
1
Blister
1
1
Fever
1
1
Pleural Effusion
1
1
Pain
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
Dec-03-2024
2
Becton Dickinson & Co.
II
Oct-12-2023
-
-