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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, blood transfusion
Regulation Description Intravascular administration set.
Product CodeBRZ
Regulation Number 880.5440
Device Class 2

Device Problems
Fluid Leak 204
Tube 130
Disconnection 100
Connector 87
Filter 27
No Flow 24
Valve(s) 20
Crack 17
Air Eliminator 16
Hole In Material 14
Failure to Prime 14
Port 13
Break 13
Cut In Material 12
Filling Problem 11
Y-Piece Connector 10
Material Puncture/Hole 9
Device Operates Differently Than Expected 9
Device Contamination with Chemical or Other Material 9
Improper Flow or Infusion 9
Connection Problem 8
Fitting Problem 7
Failure to Infuse 7
Material Deformation 6
Reflux within Device 6
Melted 4
Fracture 4
Complete Blockage 4
Device Displays Incorrect Message 4
Infusion or Flow Problem 3
Kinked 3
Material Separation 2
Cap 2
Clamp 2
Regulator 2
Contamination /Decontamination Problem 2
Material Perforation 2
Component Missing 2
Material Integrity Problem 2
Material Split, Cut or Torn 2
Protective Measures Problem 2
Scratched Material 1
Incomplete or Inadequate Connection 1
Material Twisted/Bent 1
Adverse Event Without Identified Device or Use Problem 1
Obstruction of Flow 1
Failure to Disconnect 1
Free or Unrestricted Flow 1
Detachment of Device or Device Component 1
Device Packaging Compromised 1
Backflow 1
Partial Blockage 1
Detachment Of Device Component 1
Improper or Incorrect Procedure or Method 1
Material Rupture 1
Occlusion Within Device 1
Unsealed Device Packaging 1
Product Quality Problem 1
Leak/Splash 1
Mechanical Problem 1
Gas Output Problem 1
Difficult to Flush 1
Total Device Problems 845


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