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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)
Product CodeKNT
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ABBVIE INC.
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - KIT 2
ACTA MEDICAL L.L.C.
  SUBSTANTIALLY EQUIVALENT 1
ACTUATED MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
ALAN REID
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - KIT 4
ART HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASPIRE BARIATRICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ASPIRE BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BD MEDICAL SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
BENLAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONIX DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES LLC
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
CM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODAN US CORP.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 4
CONSURE MEDICAL PVT LTD.
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC INC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LTD.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
CORPAK MEDSYSTEMS, INC. A DIVISION OF HAYLARD HEALTH
  SUBSTANTIALLY EQUIVALENT - KIT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN (DBA MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
  SUBSTANTIALLY EQUIVALENT 1
CREATIVE BALLOONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
CROSPON, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE LTD
  SUBSTANTIALLY EQUIVALENT 2
DEGANIA SILICONE LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK INC.
  SUBSTANTIALLY EQUIVALENT 1
ENTRACARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GENERICA MEDICAL INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRAVITAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
HOSPI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IMED TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENTEC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
MANUFACTURING & RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
MAXTER CATHETERS
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INNOVATION DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MRI MANUFACTURING AND RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
NASER DIB GABINET LEKARKSI NASMED
  SUBSTANTIALLY EQUIVALENT 1
NASOGASTRIC FEEDING SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOCHILD, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PROSYS INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESHAPE LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
SAINATH INTELLECTUAL PROPERTIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 3
STANDARD BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNCRO MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
THE METRIX COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TOOLS FOR SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1
URESIL, LLC
  SUBSTANTIALLY EQUIVALENT - KIT 1
VERITRACT, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 2
XERIDIEM MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1029 1029
2015 1048 1048
2016 1251 1251
2017 1672 1672
2018 1899 1899
2019 1837 1837
2020 1641 1641
2021 1652 1652
2022 1650 1650
2023 1867 1867
2024 887 1120

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6725 6958
Break 1014 1014
Fluid/Blood Leak 922 922
Insufficient Information 763 763
Leak/Splash 753 753
Detachment of Device or Device Component 709 709
Occlusion Within Device 425 425
Detachment Of Device Component 373 373
Deflation Problem 326 326
Difficult to Remove 321 321
Material Rupture 318 318
Malposition of Device 318 318
Obstruction of Flow 304 304
Device Dislodged or Dislocated 249 249
Inflation Problem 237 237
Migration or Expulsion of Device 215 215
Burst Container or Vessel 201 201
Disconnection 188 188
Kinked 166 166
Material Twisted/Bent 163 163
Material Puncture/Hole 152 152
Material Split, Cut or Torn 151 151
Material Separation 143 143
Crack 135 135
Unintended Deflation 121 121
Device Operates Differently Than Expected 119 119
Improper or Incorrect Procedure or Method 115 115
Fracture 101 101
Use of Device Problem 100 100
Migration 92 92
Appropriate Term/Code Not Available 85 85
Human-Device Interface Problem 84 84
Patient Device Interaction Problem 79 79
Knotted 79 79
Hole In Material 78 78
Material Integrity Problem 78 78
Complete Blockage 75 75
Torn Material 74 74
Difficult to Advance 70 70
Component Missing 67 67
Material Fragmentation 56 56
Patient-Device Incompatibility 53 53
No Apparent Adverse Event 51 51
Device Contamination with Chemical or Other Material 50 50
Defective Component 49 49
Entrapment of Device 48 48
Overfill 48 48
Loose or Intermittent Connection 46 46
Defective Device 46 46
Device Handling Problem 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2426 2427
Unspecified Infection 2017 2017
No Consequences Or Impact To Patient 1791 1791
No Clinical Signs, Symptoms or Conditions 1760 1760
Skin Infection 1691 1827
No Code Available 1183 1183
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 915 962
Foreign Body In Patient 498 498
Post Operative Wound Infection 487 487
Ulcer 384 384
No Information 365 365
Insufficient Information 351 351
Peritonitis 336 336
Pneumothorax 327 327
No Patient Involvement 300 300
Hemorrhage/Bleeding 270 271
Death 270 270
Bowel Perforation 243 243
Pneumonia 198 198
Perforation 187 188
Pain 162 162
Pressure Sores 158 158
Aspiration/Inhalation 130 130
Abscess 118 118
Sepsis 108 108
Abdominal Pain 107 107
Stomach Ulceration 103 103
Tissue Damage 95 95
Device Embedded In Tissue or Plaque 91 91
Blood Loss 85 85
Vomiting 77 77
Tissue Breakdown 72 72
Obstruction/Occlusion 72 72
Discomfort 70 70
Aspiration Pneumonitis 65 65
Laceration(s) 59 59
Injury 58 58
Inflammation 54 54
Ulceration 52 53
Gastrointestinal Hemorrhage 51 52
Feeding Problem 49 49
Skin Inflammation/ Irritation 47 47
Erosion 45 45
Necrosis 45 45
Fistula 43 43
Granuloma 40 40
Skin Tears 40 40
Skin Erosion 39 39
Internal Organ Perforation 39 40
Erythema 36 36

Recalls
Manufacturer Recall Class Date Posted
1 AbbVie Inc. II May-31-2017
2 AbbVie Inc. II Dec-17-2016
3 Abeon Medical Corporation II Jan-21-2016
4 Applied Medical Technology Inc II Jun-28-2024
5 Applied Medical Technology Inc III Feb-17-2017
6 Applied Medical Technology Inc II Apr-14-2016
7 Avanos Medical, Inc. II Jul-23-2024
8 Avanos Medical, Inc. I Mar-01-2024
9 Avanos Medical, Inc. I May-13-2022
10 Avanos Medical, Inc. II Feb-07-2022
11 Avanos Medical, Inc. II Dec-07-2020
12 Avanos Medical, Inc. II Sep-17-2020
13 Avanos Medical, Inc. II Nov-14-2019
14 Boston Scientific Corp II Jun-25-2015
15 Boston Scientific Corp II Jan-28-2009
16 Boston Scientific Corporation II Apr-11-2024
17 C R Bard Inc II Apr-08-2009
18 C.R. Bard Access Systems, Inc II Sep-15-2009
19 C.R. Bard Inc II Jan-25-2024
20 C.R. Bard, Inc., Urological Division III Nov-26-2010
21 CORPAK MedSystems, Inc. II May-25-2017
22 COVIDIEN LLC II Dec-11-2018
23 Churchill Medical Systems, Inc. III Mar-24-2010
24 Convatec Inc. I Jun-13-2014
25 Convatec Inc. III Aug-20-2013
26 Cook Endoscopy II Sep-01-2009
27 Cook Inc. II Mar-01-2018
28 Corpak Med Systems II Feb-22-2012
29 Covidien LLC II Feb-20-2018
30 Covidien LLC II Mar-02-2016
31 Ethox International, Inc. III Nov-22-2011
32 Hollister Incorporated II Mar-26-2021
33 Kimberly-Clark Corporation II Sep-20-2012
34 Kimberly-Clark Corporation II Feb-02-2012
35 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
36 Neomed Inc III Nov-30-2018
37 Teleflex Medical II Apr-24-2014
38 Teleflex Medical Europe Ltd II Apr-12-2018
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