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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, hemodialysis, non-implanted
Regulation Description Blood access device and accessories.
Product CodeMPB
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT - KIT 1
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 4
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
Crack 177
Leak 102
Hole in material 68
Growth, will not support 39
Kinked 34
Unknown (for use when the device problem is not known) 32
Break 25
Migration of device or device component 21
Component(s), broken 19
Physical resistance 18
Unraveled material 16
Other (for use when an appropriate device code cannot be identified) 15
Stretched 11
Dislodged 11
Material separation 11
No Known Device Problem 10
Slippage of device or device component 9
Material rupture 6
Fracture 6
Use of Device Issue 6
Restricted flowrate 5
Adaptor, failure of 5
Replace 5
Retraction problem 4
Sticking 4
Occlusion within device 4
Bent 4
Detachment of device component 4
Cut in material 4
Material deformation 4
Detachment of device or device component 4
Device, removal of (non-implant) 3
Improper or incorrect procedure or method 3
Failure to Adhere or Bond 3
Disconnection 3
Blockage within device or device component 2
Material frayed 2
Wire(s), breakage of 2
Device Issue 2
Split 2
Failure to disconnect 2
Connection issue 2
Material integrity issue 2
Material Protrusion 2
Foreign material present in device 2
No code available 2
Device handling issue 2
Infusion or flow issue 1
Protective measure issue 1
Therapeutic or diagnostic output failure 1
Torn material 1
Unintended movement 1
No Information 1
Deployment issue 1
Patient-device incompatibility 1
Aspiration issue 1
Difficult to advance 1
Extrusion 1
Fail-safe mechanism issue 1
Defective item 1
Failure to obtain samples 1
Motion detector failure 1
Implant, removal of 1
Fluid leak 1
Material erosion 1
Disassembly 1
Loss of or failure to bond 1
Device clogged 1
Coagulation in device or device ingredient 1
Difficult to insert 1
Material puncture 1
Device, or device fragments remain in patient 1
Mechanical issue 1
Total Device Problems 745

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

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Access Systems, Inc II Sep-20-2007
2 Cordis Corporation II Aug-18-2015

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