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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubes, gastrointestinal (and accessories)
Regulation Description Gastrointestinal tube and accessories.
Product CodeKNT
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 17
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 4
  SUBSTANTIALLY EQUIVALENT WITH DRUG 1
ANDERSEN PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
BD
  SUBSTANTIALLY EQUIVALENT 1
BIOENTERICS CORP
  SUBSTANTIALLY EQUIVALENT 1
BIO-RESEARCH ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 31
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 15
  SUBSTANTIALLY EQUIVALENT - KIT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 10
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
CODAN US CORP.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 3
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ENTRACARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 3
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - KIT 2
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
KENDALL
  SUBSTANTIALLY EQUIVALENT 11
  SUBSTANTIALLY EQUIVALENT - KIT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
M.C. JOHNSON CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 4
MOSS
  SUBSTANTIALLY EQUIVALENT 3
MULTI-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVARTIS
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROSS PRODUCT DIV. ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TRISTATE
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VENUSA LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 4
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
ZEVEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Balloon rupture 214
Detachment of device component 207
Device damaged prior to use 145
Leak 130
Locking mechanism failure 115
Occlusion within device 72
Crack 70
Break 65
Other (for use when an appropriate device code cannot be identified) 57
Port leak(s) 57
No code available 49
Kinked 45
Migration of device or device component 42
Fluid leak 40
Blockage within device or device component 38
Material rupture 38
Component(s), broken 37
Insufficient flow or underinfusion 35
Difficult to advance 35
Balloon leak(s) 34
Tears, rips, holes in device, device material 26
Loose or intermittent connection 25
Deflation issue 25
Device, removal of (non-implant) 25
No Known Device Problem 24
Deflation, cause unknown 20
Torn material 20
Hole in material 19
Inflation issue 19
Detachment of device or device component 16
Source, detachment from 16
Unraveled material 15
Difficult to insert 14
Wire(s), breakage of 14
Entrapment of device or device component 13
Difficult to flush 13
Difficult to open or close 13
Failure to advance 13
Loose 13
Fitting problem 13
Unknown (for use when the device problem is not known) 12
Underdelivery 12
Dull 12
Excess flow or overinfusion 12
Difficult to remove 11
Patient-device incompatibility 10
Material frayed 10
Mislabeled 10
No Information 10
Dislodged 9
Defective component 9
Obstruction within device 8
Balloon burst 8
Device clogged 8
Close, difficult to 7
Difficult to position 7
Stretched 7
Source, leak(s) from 6
Looping 6
Defective item 6
Knotted 6
Peeled 6
Material discolored 6
Balloon pinhole 6
Physical resistance 6
Device Issue 5
Device, or device fragments remain in patient 5
Foreign material 5
Malposition of device 5
Device Rinsing Issue 5
Device inoperable 5
Overdelivery 4
Device Contamination with biological material 4
Cut in material 4
Split 4
Material puncture 4
Tube(s), splitting of 4
Material perforation 4
Design/structure problem 4
Unsealed device packaging 4
Material separation 4
Bent 3
Retraction problem 3
Balloon asymmetrical 3
Component missing 3
Not Applicable 3
Slippage of device or device component 3
Material deformation 3
Contamination during use 3
Device maintenance issue 3
Corrosion 2
Sticking 2
Tube(s), defective 2
Reflux within device 2
Sharp/jagged/rough/etched/scratched 2
Use of Device Issue 2
Dislodged or dislocated 2
Collapse 2
Connection error 2
Degraded 2
Total Device Problems 2208

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 2 4 0 0 3 0
Class III 0 2 0 2 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corp II Jan-28-2009
2 Boston Scientific Corporation III Sep-17-2008
3 C R Bard Inc II Apr-08-2009
4 C R Bard Inc II Dec-12-2008
5 C.R. Bard Access Systems, Inc II Sep-15-2009
6 C.R. Bard, Inc., Urological Division III Nov-26-2010
7 Cardinal Health III Sep-21-2008
8 Churchill Medical Systems, Inc. III Mar-24-2010
9 ConvaTec II Dec-30-2008
10 Cook Endoscopy II Sep-01-2009
11 Corpak Med Systems II Feb-22-2012
12 Ethox International, Inc. III Nov-22-2011
13 Kimberly-Clark Corporation II Sep-20-2012
14 Kimberly-Clark Corporation II Feb-02-2012
15 Ross Products Division Abbott Laboratories II Jul-10-2007

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