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
catheter, continuous irrigation
Product Code
GBQ
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
9
9
2021
1
1
2022
7
7
2023
32
32
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
19
19
Break
11
11
Therapeutic or Diagnostic Output Failure
5
5
Physical Resistance/Sticking
5
5
Adverse Event Without Identified Device or Use Problem
3
3
Gas/Air Leak
3
3
Material Twisted/Bent
2
2
Leak/Splash
2
2
Detachment of Device or Device Component
2
2
Air/Gas in Device
2
2
Lack of Effect
1
1
Explosion
1
1
Unsealed Device Packaging
1
1
Difficult to Remove
1
1
Failure to Advance
1
1
Separation Failure
1
1
Failure to Cut
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
21
21
Insufficient Information
18
18
No Known Impact Or Consequence To Patient
6
6
Hemorrhage/Bleeding
2
2
Failure of Implant
2
2
Pain
2
2
Pneumothorax
2
2
Obstruction/Occlusion
1
1
Foreign Body In Patient
1
1
Unspecified Infection
1
1
Hemothorax
1
1
Hypovolemic Shock
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Unspecified Kidney or Urinary Problem
1
1
Death
1
1
-
-