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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
  1.  K780596  STOPCOCK
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 55
Disconnection 31
Leak 29
Component(s), broken 27
Crack 21
Connection issue 12
Device damaged prior to use 11
Break 10
Detachment of device component 9
Disassembly 9
Failure to prime 5
Fracture 5
Kinked 5
Filling problem 4
Air leak 4
Detachment of device or device component 4
Infusion or flow issue 3
Improper or incorrect procedure or method 3
No flow 3
Material separation 2
Material deformation 2
Normal 2
Blocked connection 2
Device packaging compromised 2
Dislodged or dislocated 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
Total Device Problems 278

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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