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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
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 103 107
2023 138 140
2024 104 105
2025 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 190 195
Misconnection 52 53
Loss of or Failure to Bond 47 47
Defective Component 25 26
Adverse Event Without Identified Device or Use Problem 25 25
Disconnection 13 13
Difficult to Remove 12 12
Break 10 10
Device Dislodged or Dislocated 10 10
Improper or Incorrect Procedure or Method 9 9
Difficult or Delayed Positioning 8 8
Leak/Splash 7 7
Contamination 6 6
Component Misassembled 6 6
Fluid/Blood Leak 5 5
Patient Device Interaction Problem 5 5
Material Twisted/Bent 5 6
Tear, Rip or Hole in Device Packaging 5 5
Mechanical Problem 4 4
Patient-Device Incompatibility 4 4
Appropriate Term/Code Not Available 4 4
Misassembled 4 5
Material Separation 4 4
Nonstandard Device 3 3
Component Missing 3 3
Material Deformation 3 3
Product Quality Problem 3 3
Separation Problem 2 2
Unsealed Device Packaging 2 2
Flaked 2 2
Positioning Problem 2 2
Difficult to Open or Close 2 2
Contamination /Decontamination Problem 2 2
Free or Unrestricted Flow 2 2
Difficult or Delayed Separation 2 2
Biocompatibility 1 1
Activation Failure 1 1
No Apparent Adverse Event 1 1
Infusion or Flow Problem 1 1
Failure to Align 1 1
Obstruction of Flow 1 1
Adhesive Too Strong 1 1
Fail-Safe Problem 1 1
Shipping Damage or Problem 1 1
Key or Button Unresponsive/not Working 1 1
Inadequate Instructions for Healthcare Professional 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Crack 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 391 398
Insufficient Information 17 17
Hemorrhage/Bleeding 9 9
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 7 7
Hypersensitivity/Allergic reaction 6 6
Skin Inflammation/ Irritation 6 6
Skin Tears 5 5
Skin Erosion 4 4
Blister 3 3
Ulcer 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Inflammation 2 2
Abrasion 2 2
Itching Sensation 2 2
Local Reaction 2 2
Burn(s) 2 2
Dyspnea 2 2
No Consequences Or Impact To Patient 2 2
Tissue Breakdown 2 2
Unspecified Infection 1 1
Aspiration/Inhalation 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
Caustic/Chemical Burns 1 1
Bacterial Infection 1 1
Pressure Sores 1 1

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