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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, peritoneal, long-term indwelling
Regulation Description Peritoneal dialysis system and accessories.
Product CodeFJS
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENVER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
Lifemed of California
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT - KIT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Hole in material 134
Leak 82
Crack 20
Break 15
No Known Device Problem 14
Disconnection 12
Restricted flowrate 8
Unknown (for use when the device problem is not known) 8
Split 8
Fluid leak 7
Growth, will not support 4
Migration of device or device component 4
Material separation 3
Implant, removal of 3
Device or device component damaged by another device 3
Material integrity issue 3
Fracture 3
Detachment of device component 3
Unintended movement 3
Component(s), broken 2
Loose or intermittent connection 2
Kinked 2
Detachment of device or device component 2
Device operates differently than expected 1
Cut in material 1
Dislodged or dislocated 1
Improper flow or infusion 1
Tears, rips, holes in device, device material 1
Improper or incorrect procedure or method 1
Blood pooling 1
Delivered as unsterile product 1
Material puncture 1
Failure to reset 1
Material rupture 1
Mechanical issue 1
Intraprocedure, fire or flash during 1
Bent 1
Contamination during use 1
Dislodged 1
Displacement 1
Material discolored 1
No Information 1
Torn material 1
Total Device Problems 365

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

Recalls
Manufacturer Recall Class Date Posted
1 Bard Access Systems III Aug-08-2011
2 Pfm Medical Inc II Dec-12-2014

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