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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, intravascular catheter securement
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

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 181 181
Loss of or Failure to Bond 45 45
Misconnection 35 35
Defective Component 21 21
Adverse Event Without Identified Device or Use Problem 17 17
Difficult to Remove 10 10
Break 9 9
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
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
Appropriate Term/Code Not Available 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 340 340
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 5 5
Skin Tears 5 5
Skin Erosion 4 4
Skin Inflammation/ Irritation 3 3
Ulcer 3 3
Inflammation 2 2
Exsanguination 2 2
Abrasion 2 2
Dyspnea 2 2
No Consequences Or Impact To Patient 2 2
Tissue Breakdown 2 2
Aspiration/Inhalation 1 1
Chemical Exposure 1 1
Localized Skin Lesion 1 1
Erythema 1 1
Unspecified Hepatic or Biliary Problem 1 1
Renal Impairment 1 1
Pain 1 1
Hypoglycemia 1 1
Anxiety 1 1
Contact Dermatitis 1 1
Phlebitis 1 1
Pressure Sores 1 1

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