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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
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 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 180
Leak 104
Hole in material 69
Growth, will not support 39
Kinked 39
Unknown (for use when the device problem is not known) 32
Break 30
Unraveled material 23
Physical resistance 21
Migration of device or device component 21
Component(s), broken 19
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
Fracture 7
Material rupture 6
Use of Device Issue 6
Detachment of device or device component 5
Restricted flowrate 5
Adaptor, failure of 5
Replace 5
Retraction problem 5
Sticking 4
Occlusion within device 4
Bent 4
Detachment of device component 4
Fluid leak 4
Device operates differently than expected 4
Material deformation 4
Cut in material 4
Split 3
Improper or incorrect procedure or method 3
Device, removal of (non-implant) 3
Failure to Adhere or Bond 3
Disconnection 3
Infusion or flow issue 3
No code available 2
Device handling issue 2
Difficult to remove 2
Blockage within device or device component 2
Material frayed 2
Connection issue 2
Material integrity issue 2
Material Protrusion 2
Foreign material present in device 2
Failure to disconnect 2
Wire(s), breakage of 2
Device Issue 2
Failure to advance 1
Failure to obtain samples 1
Defective item 1
Motion detector failure 1
Implant, removal of 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
Material erosion 1
Disassembly 1
Loss of or failure to bond 1
Device clogged 1
Coagulation in device or device ingredient 1
Mechanical issue 1
Difficult to insert 1
Material puncture 1
Device, or device fragments remain in patient 1
Total Device Problems 787

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 1 0 0 0 0 0 0 0 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-12-2017
2 C.R. Bard Access Systems, Inc II Sep-20-2007
3 Cordis Corporation II Aug-18-2015

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