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
tray, catheterization, sterile urethral, with or without catheter (kit)
Product Code
FCM
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
COLOPLAST
SUBSTANTIALLY EQUIVALENT
1
1. K223821
Self-Cath Closed System
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
5
5
2016
14
14
2017
33
33
2018
61
61
2019
79
79
2020
86
86
2021
85
85
2022
59
59
2023
48
48
2024
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Component Missing
69
69
Product Quality Problem
48
48
Improper Chemical Reaction
40
40
Difficult to Insert
39
39
Component Misassembled
30
30
Adverse Event Without Identified Device or Use Problem
23
23
Fluid/Blood Leak
23
23
Patient-Device Incompatibility
21
21
Material Twisted/Bent
21
21
Biocompatibility
18
18
Inaccurate Flow Rate
18
18
Nonstandard Device
17
17
Incorrect Measurement
17
17
Material Integrity Problem
15
15
Leak/Splash
13
13
Unintended Deflation
13
13
Deflation Problem
12
12
Defective Device
12
12
Material Deformation
10
10
Misassembled
10
10
No Flow
10
10
Device Operates Differently Than Expected
9
9
Deformation Due to Compressive Stress
8
8
Partial Blockage
8
8
Gel Leak
8
8
Material Fragmentation
7
7
Detachment of Device or Device Component
6
6
Sharp Edges
6
6
Contamination /Decontamination Problem
5
5
Material Rupture
5
5
Bent
5
5
Break
5
5
Inadequacy of Device Shape and/or Size
4
4
Structural Problem
4
4
Insufficient Information
4
4
Appropriate Term/Code Not Available
3
3
Therapeutic or Diagnostic Output Failure
3
3
Moisture or Humidity Problem
3
3
Premature Separation
3
3
Material Split, Cut or Torn
3
3
Inadequate Lubrication
3
3
Failure to Deflate
3
3
Shipping Damage or Problem
3
3
Short Fill
3
3
Defective Component
3
3
Tear, Rip or Hole in Device Packaging
3
3
Obstruction of Flow
3
3
Burst Container or Vessel
3
3
Disconnection
3
3
Difficult to Remove
3
3
Kinked
3
3
Loose or Intermittent Connection
2
2
Unsealed Device Packaging
2
2
Restricted Flow rate
2
2
Complete Blockage
2
2
Incomplete or Missing Packaging
2
2
Device Damaged Prior to Use
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Material Protrusion/Extrusion
2
2
Infusion or Flow Problem
2
2
Device Dislodged or Dislocated
2
2
Device Markings/Labelling Problem
2
2
Physical Resistance/Sticking
2
2
Scratched Material
2
2
Packaging Problem
2
2
Positioning Problem
1
1
Protective Measures Problem
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Material Too Soft/Flexible
1
1
Device Handling Problem
1
1
Patient Device Interaction Problem
1
1
Illegible Information
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Ingredient or Reagent Problem
1
1
Device Displays Incorrect Message
1
1
Folded
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper Flow or Infusion
1
1
Suction Problem
1
1
Sticking
1
1
Device Inoperable
1
1
Fungus in Device Environment
1
1
Material Discolored
1
1
Fracture
1
1
Inflation Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Material Puncture/Hole
1
1
Delivered as Unsterile Product
1
1
Retraction Problem
1
1
Material Separation
1
1
Moisture Damage
1
1
Migration or Expulsion of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
189
189
No Known Impact Or Consequence To Patient
142
142
No Consequences Or Impact To Patient
122
122
Urinary Tract Infection
52
52
No Patient Involvement
45
45
Pain
17
17
Hemorrhage/Bleeding
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Patient Problem/Medical Problem
11
11
No Information
9
9
Discomfort
8
8
Insufficient Information
7
7
Foreign Body In Patient
6
6
Blood Loss
6
6
No Code Available
5
5
Tissue Damage
4
4
Unspecified Infection
4
4
Injury
3
3
Urinary Retention
2
2
Irritation
2
2
Abrasion
2
2
Sepsis
2
2
Tissue Breakdown
2
2
Skin Tears
2
2
Hematuria
2
2
Pressure Sores
1
1
Distress
1
1
Skin Inflammation/ Irritation
1
1
Urinary Incontinence
1
1
Exposure to Body Fluids
1
1
Burn(s)
1
1
Hypersensitivity/Allergic reaction
1
1
Failure of Implant
1
1
Nausea
1
1
Staphylococcus Aureus
1
1
Burning Sensation
1
1
Reaction
1
1
Irritability
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health
II
Dec-02-2022
2
Cardinal Health 200, LLC
I
Feb-16-2024
3
Customed, Inc
II
Mar-21-2012
4
Go Medical Industries Pty., Ltd.
II
Oct-21-2011
5
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
6
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
7
Nurse Assist, Inc
II
May-25-2011
8
Teleflex Medical
III
Aug-06-2014
-
-