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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
2019 4 4
2020 4 4
2021 1 1
2022 1 1
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8 8
Difficult to Open or Close 2 2
Loose or Intermittent Connection 2 2
Free or Unrestricted Flow 2 2
Mechanical Problem 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Disconnection 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 1 1

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