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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 2
  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 4
  SUBSTANTIALLY EQUIVALENT - KIT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
Crack 165
Leak 75
Hole in material 64
Growth, will not support 39
Unknown (for use when the device problem is not known) 32
Component(s), broken 19
Break 15
Other (for use when an appropriate device code cannot be identified) 15
Dislodged 11
Slippage of device or device component 9
No Known Device Problem 9
Unraveled material 8
Use of Device Issue 6
Material separation 6
Migration of device or device component 6
Replace 5
Material rupture 5
Restricted flowrate 5
Adaptor, failure of 5
Detachment of device component 4
Retraction problem 4
Occlusion within device 4
Cut in material 4
Device, removal of (non-implant) 3
Failure to Adhere or Bond 3
Disconnection 3
Fracture 2
Material frayed 2
Kinked 2
Detachment of device or device component 2
Material deformation 2
Wire(s), breakage of 2
Material Protrusion 2
No code available 2
Implant, removal of 1
Failure to obtain samples 1
Split 1
Failure to disconnect 1
Defective item 1
Material integrity issue 1
Torn material 1
Foreign material present in device 1
Aspiration issue 1
Connection issue 1
Material puncture 1
Device, or device fragments remain in patient 1
Stretched 1
Improper or incorrect procedure or method 1
Motion detector failure 1
Material erosion 1
Disassembly 1
Bent 1
Blockage within device or device component 1
Loss of or failure to bond 1
Device clogged 1
Coagulation in device or device ingredient 1
Total Device Problems 562

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

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Access Systems, Inc II Sep-20-2007

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