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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, fluid delivery
Regulation Description Intravascular administration set.
Product CodeFPK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 8 8
2022 7 7
2023 15 15
2024 8 8
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 11 11
No Flow 10 10
Leak/Splash 9 9
Fluid/Blood Leak 8 8
Suction Failure 8 8
Disconnection 7 7
Break 5 5
Detachment of Device or Device Component 3 3
Complete Blockage 2 2
Crack 2 2
Accessory Incompatible 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Restricted Flow rate 1 1
Defective Device 1 1
Free or Unrestricted Flow 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Insufficient Information 8 8
Hemorrhage/Bleeding 4 4
Blood Loss 2 2
Therapeutic Response, Decreased 1 1
No Consequences Or Impact To Patient 1 1
Chemical Exposure 1 1

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