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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
flowmeter, tube, thorpe, back-pressure compensated
Product Code
CAX
Regulation Number
868.2340
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2017
4
4
2018
3
3
2019
6
6
2020
1
1
2021
6
6
2022
1
1
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
4
4
Peeled/Delaminated
4
4
Burst Container or Vessel
3
3
Misassembly by Users
2
2
Defective Component
2
2
Therapeutic or Diagnostic Output Failure
2
2
Improper or Incorrect Procedure or Method
2
2
Gas Output Problem
2
2
Break
1
1
Material Twisted/Bent
1
1
Use of Device Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Material Rupture
1
1
Inadequate User Interface
1
1
Detachment Of Device Component
1
1
Unsealed Device Packaging
1
1
Excess Flow or Over-Infusion
1
1
Infusion or Flow Problem
1
1
Material Separation
1
1
Free or Unrestricted Flow
1
1
Detachment of Device or Device Component
1
1
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Inadequate Instructions for Healthcare Professional
1
1
Air Leak
1
1
Material Fragmentation
1
1
Device Inoperable
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
8
8
No Clinical Signs, Symptoms or Conditions
6
6
Death
5
5
Low Oxygen Saturation
5
5
No Consequences Or Impact To Patient
2
2
No Information
1
1
Insufficient Information
1
1
Cardiopulmonary Arrest
1
1
Bradycardia
1
1
-
-