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
collector, urine, pediatric, for indwelling catheter
Regulation Description
Urine collector and accessories.
Product Code
FFH
Regulation Number
876.5250
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
1
1
2022
5
5
2023
12
12
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Disconnection
5
5
Material Fragmentation
5
5
Fitting Problem
3
3
Component Missing
2
2
Difficult to Remove
2
2
Component Misassembled
2
2
Material Twisted/Bent
2
2
Fluid/Blood Leak
1
1
Device Contamination with Chemical or Other Material
1
1
Loose or Intermittent Connection
1
1
Inaccurate Flow Rate
1
1
Difficult to Open or Remove Packaging Material
1
1
Defective Device
1
1
Gel Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
20
20
Foreign Body In Patient
2
2
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Patient Involvement
1
1
No Known Impact Or Consequence To Patient
1
1
-
-