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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stopcock, i.v. set
Regulation Description Intravascular administration set.
Product CodeFMG
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 4
HALKEY-ROBERTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
MEDEGEN
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 65
Leak 36
Disconnection 35
Component(s), broken 27
Crack 25
Connection issue 15
Detachment of device component 14
Break 12
Device damaged prior to use 11
Disassembly 9
Failure to prime 5
Fracture 5
Kinked 5
Dislodged or dislocated 5
Detachment of device or device component 4
Filling problem 4
Air leak 4
Blocked connection 3
Infusion or flow issue 3
Improper or incorrect procedure or method 3
No flow 3
Material separation 2
Material deformation 2
Normal 2
Device packaging compromised 2
Reflux within device 2
Loose or intermittent connection 2
Misconnection 1
Device, or device fragments remain in patient 1
Foreign material 1
Inaccurate flowrate 1
Foreign material present in device 1
Incompatibility problem 1
Sticking 1
Use of Device Issue 1
Insufficient flow or underinfusion 1
Failure to infuse 1
Tube(s), buckling of 1
Split 1
Failure to disconnect 1
Total Device Problems 318

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 1 1 0 1 1 2 0 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jan-11-2012
2 Baxter Healthcare Corp. II Jun-22-2011
3 Baxter Healthcare Corp. II Dec-09-2010
4 ICU Medical, Inc. II May-07-2015
5 ICU Medical, Inc. I Sep-19-2014
6 ICU Medical, Inc. II Aug-02-2012
7 ICU Medical, Inc. II Sep-16-2008
8 Merit Medical Systems, Inc. II May-31-2007
9 Value Plastics, Inc. II Mar-09-2016

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