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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 - WITH DRUG 1
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 4
  SUBSTANTIALLY EQUIVALENT 17
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 - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT 31
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 15
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT - KIT 4
  SUBSTANTIALLY EQUIVALENT 10
CODAN US CORP.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 4
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 9
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 4
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ENTRACARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 5
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 - KIT 2
  SUBSTANTIALLY EQUIVALENT 5
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 11
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
M.C. JOHNSON CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
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
No Known Device Problem 285
Leak 278
Detachment of device component 270
Occlusion within device 217
Balloon rupture 215
Break 167
Device damaged prior to use 156
Deflation issue 142
Inflation issue 140
Locking mechanism failure 115
Migration of device or device component 85
Fluid leak 80
Crack 75
Kinked 74
Material rupture 63
Other (for use when an appropriate device code cannot be identified) 60
No code available 58
Port leak(s) 57
Blockage within device or device component 51
Torn material 50
Burst 44
Detachment of device or device component 42
Difficult to advance 42
Hole in material 40
Overfill 40
Component(s), broken 37
Improper or incorrect procedure or method 35
Insufficient flow or underinfusion 35
Balloon leak(s) 34
No Information 29
Tears, rips, holes in device, device material 26
Use of Device Issue 25
Loose or intermittent connection 25
Human-Device Interface Issue 25
Device, removal of (non-implant) 25
Entrapment of device or device component 23
Material separation 23
Defective component 20
Knotted 20
Deflation, cause unknown 20
Defective item 19
Difficult to remove 18
Malposition of device 17
Source, detachment from 16
Difficult to insert 16
Difficult to flush 16
Device abrasion from instrument or another object 16
Fitting problem 15
Unraveled material 15
Wire(s), breakage of 14
Split 14
Failure to advance 13
Difficult to open or close 13
Difficult to position 13
Loose 13
Excess flow or overinfusion 13
Inability to irrigate 12
Unknown (for use when the device problem is not known) 12
Dull 12
Obstruction within device 12
Underdelivery 12
Patient-device incompatibility 11
Material frayed 11
Loss of or failure to bond 11
Disconnection 10
Dislodged 10
Mislabeled 10
Device operates differently than expected 10
Material deformation 10
Device Issue 9
Device clogged 9
Retraction problem 9
Material puncture 8
Stretched 8
Device inoperable 8
Balloon burst 8
Physical resistance 8
Close, difficult to 7
Material discolored 7
Cut in material 7
Component missing 7
Product quality issue 7
User used incorrect product for intended use 6
Peeled 6
Source, leak(s) from 6
Material perforation 6
Looping 6
Fracture 6
Balloon pinhole 6
Device handling issue 6
Positioning Issue 5
Connection issue 5
Foreign material 5
Device Rinsing Issue 5
Device, or device fragments remain in patient 5
Increase in pressure 4
Unsealed device packaging 4
Slippage of device or device component 4
Out-of-box failure 4
Overdelivery 4
Total Device Problems 3827

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 1 2 4 0 0 3 0 1 1 3
Class III 0 2 0 2 1 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abeon Medical Corporation II Jan-21-2016
2 Applied Medical Technology Inc II Apr-14-2016
3 Boston Scientific Corp II Jun-25-2015
4 Boston Scientific Corp II Jan-28-2009
5 Boston Scientific Corporation III Sep-17-2008
6 C R Bard Inc II Apr-08-2009
7 C R Bard Inc II Dec-12-2008
8 C.R. Bard Access Systems, Inc II Sep-15-2009
9 C.R. Bard, Inc., Urological Division III Nov-26-2010
10 Cardinal Health III Sep-21-2008
11 Churchill Medical Systems, Inc. III Mar-24-2010
12 ConvaTec II Dec-30-2008
13 Convatec Inc. I Jun-13-2014
14 Convatec Inc. III Aug-20-2013
15 Cook Endoscopy II Sep-01-2009
16 Corpak Med Systems II Feb-22-2012
17 Covidien LLC II Mar-02-2016
18 Ethox International, Inc. III Nov-22-2011
19 Kimberly-Clark Corporation II Sep-20-2012
20 Kimberly-Clark Corporation II Feb-02-2012
21 Ross Products Division Abbott Laboratories II Jul-10-2007
22 Teleflex Medical II Apr-24-2014

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