Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device device, intravascular catheter securement
Regulation Description Intravascular catheter securement device.
Product CodeKMK
Regulation Number 880.5210
Device Class 1

MDR Year MDR Reports MDR Events
2020 14 14
2021 33 33
2022 103 103
2023 140 140
2024 105 105
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 182 182
Loss of or Failure to Bond 47 47
Misconnection 38 38
Defective Component 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Break 10 10
Difficult to Remove 10 10
Device Dislodged or Dislocated 9 9
Improper or Incorrect Procedure or Method 8 8
Difficult or Delayed Positioning 8 8
Leak/Splash 6 6
Contamination 6 6
Disconnection 5 5
Patient Device Interaction Problem 5 5
Material Twisted/Bent 5 5
Fluid/Blood Leak 4 4
Component Misassembled 4 4
Material Separation 4 4
Patient-Device Incompatibility 4 4
Mechanical Problem 4 4
Misassembled 3 3
Tear, Rip or Hole in Device Packaging 3 3
Appropriate Term/Code Not Available 3 3
Nonstandard Device 3 3
Component Missing 2 2
Contamination /Decontamination Problem 2 2
Unsealed Device Packaging 2 2
Material Deformation 2 2
Difficult or Delayed Separation 2 2
Crack 2 2
Flaked 2 2
Separation Problem 2 2
Adhesive Too Strong 1 1
Failure to Align 1 1
Fail-Safe Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Device Damaged Prior to Use 1 1
Free or Unrestricted Flow 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Migration or Expulsion of Device 1 1
Difficult to Open or Close 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 346 346
Insufficient Information 13 13
Hemorrhage/Bleeding 10 10
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 7 7
Hypersensitivity/Allergic reaction 6 6
Skin Tears 5 5
Skin Inflammation/ Irritation 4 4
Skin Erosion 4 4
Ulcer 3 3
Exsanguination 2 2
Inflammation 2 2
Abrasion 2 2
Dyspnea 2 2
No Consequences Or Impact To Patient 2 2
Tissue Breakdown 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Aspiration/Inhalation 1 1
Local Reaction 1 1
Chemical Exposure 1 1
Localized Skin Lesion 1 1
Erythema 1 1
Pain 1 1
Unspecified Hepatic or Biliary Problem 1 1
Renal Impairment 1 1
Hypoglycemia 1 1
Anxiety 1 1
Contact Dermatitis 1 1
Phlebitis 1 1
Pressure Sores 1 1

-
-