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, (and accessories) for indwelling catheter
Regulation Description
Urine collector and accessories.
Product Code
KNX
Regulation Number
876.5250
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
215
215
2021
209
209
2022
167
167
2023
178
178
2024
167
167
2025
47
47
Device Problems
MDRs with this Device Problem
Events in those MDRs
Restricted Flow rate
346
346
Deformation Due to Compressive Stress
141
141
Component Misassembled
63
63
Fluid/Blood Leak
54
54
Component Missing
48
48
Material Twisted/Bent
42
42
Obstruction of Flow
33
33
Partial Blockage
27
27
Physical Resistance/Sticking
25
25
Adverse Event Without Identified Device or Use Problem
22
22
No Flow
18
18
Deflation Problem
18
18
Disconnection
17
17
Biocompatibility
17
17
Leak/Splash
15
15
Detachment of Device or Device Component
15
15
Device Contamination with Chemical or Other Material
15
15
Material Fragmentation
14
14
Inaccurate Flow Rate
12
12
Material Deformation
12
12
Nonstandard Device
11
11
Difficult to Open or Close
11
11
Improper Flow or Infusion
8
8
Use of Device Problem
7
7
Infusion or Flow Problem
7
7
Material Split, Cut or Torn
7
7
Device Handling Problem
7
7
Material Too Soft/Flexible
6
6
Unintended Deflation
6
6
Patient Device Interaction Problem
6
6
Incorrect Measurement
6
6
Appropriate Term/Code Not Available
5
5
Fracture
5
5
Therapeutic or Diagnostic Output Failure
5
5
Break
5
5
Difficult to Remove
4
4
Illegible Information
4
4
Material Puncture/Hole
4
4
Difficult to Open or Remove Packaging Material
4
4
Material Rupture
4
4
Fungus in Device Environment
3
3
Expiration Date Error
3
3
Defective Device
3
3
Failure to Deflate
3
3
Inadequate Instructions for Healthcare Professional
3
3
Missing Information
3
3
Short Fill
3
3
Material Too Rigid or Stiff
3
3
Complete Blockage
3
3
Activation Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
679
679
No Consequences Or Impact To Patient
155
155
No Known Impact Or Consequence To Patient
93
93
Urinary Tract Infection
42
42
No Patient Involvement
36
36
Pain
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Unspecified Infection
17
17
Urinary Retention
17
17
Discomfort
16
16
Insufficient Information
12
12
Exposure to Body Fluids
7
7
Cramp(s) /Muscle Spasm(s)
5
5
Patient Problem/Medical Problem
4
4
No Code Available
4
4
Hematuria
4
4
Skin Inflammation/ Irritation
4
4
Micturition Urgency
4
4
Abdominal Distention
3
3
Foreign Body In Patient
3
3
Hemorrhage/Bleeding
3
3
Abdominal Pain
2
2
Sepsis
2
2
Abrasion
2
2
Purulent Discharge
2
2
Itching Sensation
2
2
Fever
2
2
Rash
2
2
Pressure Sores
2
2
Muscle Spasm(s)
2
2
Kidney Infection
1
1
Distress
1
1
Thrombus
1
1
Internal Organ Perforation
1
1
Therapeutic Effects, Unexpected
1
1
Bacterial Infection
1
1
Anxiety
1
1
Tachycardia
1
1
Scar Tissue
1
1
Fall
1
1
Swelling
1
1
Thrombosis/Thrombus
1
1
Injury
1
1
Shock, Surgical
1
1
Chills
1
1
Burning Sensation
1
1
Irritation
1
1
Skin Discoloration
1
1
Perforation
1
1
Head Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
-
-