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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
2021 8 8
2022 7 7
2023 15 15
2024 8 8
2025 30 30
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 29 29
Break 24 24
Disconnection 15 15
Leak/Splash 11 11
Defective Component 11 11
No Flow 10 10
Suction Failure 8 8
Detachment of Device or Device Component 6 6
Material Separation 4 4
Crack 3 3
Material Fragmentation 2 2
Separation Problem 1 1
Complete Blockage 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Backflow 1 1
Use of Device Problem 1 1
Fracture 1 1
Suction Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75 75
Insufficient Information 9 9
Hemorrhage/Bleeding 5 5
Chemical Exposure 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Aug-12-2025
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