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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, line
Product CodeFKK
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 3 3
2018 1 1
2019 4 4
2020 4 4
2021 1 1
2022 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7 7
Loose or Intermittent Connection 2 2
Improper or Incorrect Procedure or Method 2 2
Device Displays Incorrect Message 2 2
Difficult to Open or Close 2 2
Free or Unrestricted Flow 2 2
Disconnection 1 1
Failure of Device to Self-Test 1 1
Connection Problem 1 1
Device Operates Differently Than Expected 1 1
Defective Component 1 1
Mechanical Problem 1 1
Sticking 1 1
Hole In Material 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 5 5
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2

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