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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, umbilical artery
Regulation Description Intravascular catheter.
Product CodeFOS
Regulation Number 880.5200
Device Class 2

Device Problems
Leak/Splash 117
Fluid Leak 54
Break 36
Crack 20
Catheter 14
Material Fragmentation 10
Fracture 8
Use of Device Problem 5
Complete Blockage 4
Patient Device Interaction Problem 4
Material Puncture/Hole 4
Migration 4
Appropriate Term/Code Not Available 3
Hole In Material 3
Infusion or Flow Problem 3
Obstruction of Flow 3
Adverse Event Without Identified Device or Use Problem 3
Hub 3
Material Integrity Problem 3
Housing 2
Material Rupture 2
Device Operates Differently Than Expected 2
Structural Problem 2
Detachment of Device or Device Component 1
Device Markings/Labelling Problem 1
Material Split, Cut or Torn 1
Improper or Incorrect Procedure or Method 1
Material Perforation 1
Connection Problem 1
Air Leak 1
Filtration Problem 1
Improper Flow or Infusion 1
Positioning Problem 1
Material Separation 1
Material Too Rigid or Stiff 1
Total Device Problems 321


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