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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, gastro-enterostomy
Regulation Description Gastrointestinal tube and accessories.
Product CodeKGC
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 53
Peeled 29
Break 20
Leak 16
Burst 13
No code available 9
Fluid leak 8
Occlusion within device 8
Difficult to position 7
No Known Device Problem 6
Tears, rips, holes in device, device material 5
Dull 5
Difficult to advance 5
Device clogged 5
Migration of device or device component 5
Hole in material 5
Other (for use when an appropriate device code cannot be identified) 4
Split 4
Use of Device Issue 3
Improper or incorrect procedure or method 3
Torn material 3
Material rupture 3
Material separation 3
Source, detachment from 3
Stretched 3
Blockage within device or device component 3
Difficult to insert 3
Mislabeled 3
Crack 3
Component(s), broken 2
Foreign material 2
No Information 2
Detachment of device or device component 2
Material deformation 2
Difficult to open or close 2
Human-Device Interface Issue 1
Infusion or flow issue 1
Malfunction 1
Cut in material 1
Physical resistance 1
Failure to cut 1
Defective item 1
Locking mechanism failure 1
Close, difficult to 1
Catheter withdrawal interference 1
Deployment issue 1
Device markings issue 1
Material frayed 1
Premature deployment 1
Difficult to remove 1
Port leak(s) 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Component missing 1
Wire(s), breakage of 1
Degraded 1
Disconnection 1
Normal 1
Material invagination 1
Kinked 1
Total Device Problems 277

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 1 1 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 Argon Medical Devices, Inc II Jun-02-2010
2 Boston Scientific Corp II Dec-10-2015
3 C R Bard Inc II Sep-17-2009

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