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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, subclavian
Regulation Description Blood access device and accessories.
Product CodeLFJ
Regulation Number 876.5540
Device Class 3


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 4
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 7
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 30
Crack 26
Kinked 23
Unraveled material 19
Physical resistance 14
Break 9
Hole in material 8
Volume accuracy issue 8
Occlusion within device 6
No flow 4
Material separation 3
Fracture 3
Material frayed 3
Bent 3
Component(s), broken 3
Detachment of device component 2
Fluid leak 2
Device, or device fragments remain in patient 2
Difficult to remove 2
Other (for use when an appropriate device code cannot be identified) 2
Device, removal of (non-implant) 2
Sticking 2
No Known Device Problem 2
Torn material 2
No Information 1
No code available 1
Stretched 1
Detachment of device or device component 1
Device packaging compromised 1
Device-device incompatibility 1
Difficult to advance 1
Dislodged or dislocated 1
Expulsion 1
Incorrect device or component shipped 1
Material deformation 1
Mechanical jam 1
Unknown (for use when the device problem is not known) 1
Failure to disconnect 1
Material rupture 1
Material fragmentation 1
Migration of device or device component 1
Decoupling 1
Air leak 1
Device clogged 1
Total Device Problems 200

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 0 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 Medical Components, Inc dba MedComp II Feb-10-2015

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