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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


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  1.  K912103  LIFESHIELD EXTENSION SET
  2.  K941214  LIFESHIELD EXTENSION SET
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
VENUSA LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 92
Failure to deliver 78
Disconnection 63
Material separation 51
Air leak 37
Valve(s), failure of 34
Material rupture 20
Break 17
Crack 6
Occlusion within device 6
Overdelivery 6
Sticking 5
Particulates 4
Insufficient flow or underinfusion 4
Excess flow or overinfusion 4
Incorrect measurement 4
Leak 3
Detachment of device component 3
Tube(s), splitting of 3
No flow 3
Failure to shut off 2
Split 2
Inaccurate delivery 2
Tears, rips, holes in device, device material 2
Normal 2
Difficult to insert 2
Kinked 1
Foreign material 1
Loose 1
Disassembly 1
Device Cleaning Issue 1
Component(s), broken 1
Tube(s), shattering of 1
Failure to prime 1
Reflux within device 1
Difficult to remove 1
Failure to infuse 1
Unknown (for use when the device problem is not known) 1
Valve(s), sticking 1
Device operates differently than expected 1
Device Issue 1
Free or unrestricted flow 1
No Known Device Problem 1
Total Device Problems 472

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 MOOG Medical Devices Group I May-30-2012
2 Mentor Texas, Inc II Sep-05-2008

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