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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
2021 33 33
2022 103 107
2023 138 140
2024 104 105
2025 75 75
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 194 199
Misconnection 64 65
Loss of or Failure to Bond 51 51
Adverse Event Without Identified Device or Use Problem 26 26
Defective Component 25 26
Difficult to Remove 18 18
Disconnection 11 11
Device Dislodged or Dislocated 10 10
Break 9 9
Improper or Incorrect Procedure or Method 9 9
Difficult or Delayed Positioning 8 8
Unexpected Color 7 7
Material Twisted/Bent 6 7
Contamination 6 6
Fluid/Blood Leak 6 6
Leak/Splash 5 5
Product Quality Problem 5 5
Contamination /Decontamination Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Patient Device Interaction Problem 5 5
Appropriate Term/Code Not Available 4 4
Material Deformation 4 4
Component Missing 4 4
Patient-Device Incompatibility 4 4
Material Separation 4 4
Misassembled 4 5
Mechanical Problem 4 4
Obstruction of Flow 3 3
Failure to Align 3 3
Component Misassembled 3 3
Positioning Problem 2 2
Separation Problem 2 2
Difficult or Delayed Separation 2 2
Connection Problem 2 2
Difficult to Open or Close 2 2
Free or Unrestricted Flow 2 2
Nonstandard Device 2 2
Unsealed Device Packaging 2 2
Shipping Damage or Problem 1 1
Migration or Expulsion of Device 1 1
Crack 1 1
Infusion or Flow Problem 1 1
Fail-Safe Problem 1 1
Defective Device 1 1
Biocompatibility 1 1
Key or Button Unresponsive/not Working 1 1
Adhesive Too Strong 1 1
Physical Resistance/Sticking 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 435
Insufficient Information 18 18
Hemorrhage/Bleeding 9 9
Hypersensitivity/Allergic reaction 7 7
Skin Inflammation/ Irritation 6 6
Skin Tears 5 5
Blister 4 4
Skin Erosion 4 4
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
Erythema 2 2
Dyspnea 2 2
Tissue Breakdown 2 2
Unspecified Infection 1 1
Aspiration/Inhalation 1 1
Chemical Exposure 1 1
Localized Skin Lesion 1 1
Discomfort 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
No Consequences Or Impact To Patient 1 1
Pressure Sores 1 1
Unintended Extubation 1 1

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