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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, fistula
Regulation Description Blood access device and accessories.
Product CodeFIE
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
JMS
  SUBSTANTIALLY EQUIVALENT 12
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 6
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 6
NISSHO CORP
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Dislodged 27
No Known Device Problem 15
Disconnection 9
Dislodged or dislocated 5
Detachment of device component 5
Crack 5
Retraction problem 4
Material separation 4
Use of Device Issue 4
Detachment of device or device component 4
Device Issue 4
Not Applicable 3
Hole in material 3
Leak 2
Needle, unsheathed 2
Occlusion within device 2
Safety interlock(s) inadequate 2
No Information 2
Dull 2
Unknown (for use when the device problem is not known) 2
Cut in material 2
Structural problem 1
Defective component 1
Malfunction 1
Fitting problem 1
Other (for use when an appropriate device code cannot be identified) 1
Difficult to remove 1
Improper or incorrect procedure or method 1
Mechanical issue 1
Fluid leak 1
Material fragmentation 1
Unintended arm motion 1
Loss of or failure to bond 1
Total Device Problems 120

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medisystems Corp II Feb-29-2012
2 Medisystems a NX Stage Company II Jan-24-2013

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