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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

Device Problems
Fluid Leak 8
Adapter (Adaptor) 6
Occlusion Within Device 6
Break 5
Disconnection 5
Insufficient Flow or Under Infusion 4
Leak / Splash 4
Detachment Of Device Component 3
Tube 3
No Apparent Adverse Event 3
Valve 2
Y-Piece Connector 2
Material Disintegration 2
Material Separation 2
Loose or Intermittent Connection 2
Crack 2
Split 2
Insufficient Information 2
Detachment of Device or device Component 1
Inaccurate Delivery 1
Sticking 1
One-Way Valve 1
Disassembly 1
Difficult to Flush 1
Failure to Deliver 1
Adverse Event Without Identified Device or Use Problem 1
Dial 1
Total Device Problems 72

Recalls
Manufacturer Recall Class Date Posted
1 Hospira Inc. II Jan-11-2017
2 Medtronic Inc. II Nov-18-2017

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