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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 - KIT 2
  SUBSTANTIALLY EQUIVALENT 4
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 - KIT 4
  SUBSTANTIALLY EQUIVALENT 5
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 605 741

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6631 6767
Break 991 991
Fluid/Blood Leak 913 913
Insufficient Information 763 763
Leak/Splash 743 743
Detachment of Device or Device Component 696 696
Occlusion Within Device 425 425
Detachment Of Device Component 373 373
Deflation Problem 326 326
Difficult to Remove 316 316
Material Rupture 302 302
Malposition of Device 299 299
Obstruction of Flow 294 294
Device Dislodged or Dislocated 247 247
Inflation Problem 233 233
Migration or Expulsion of Device 215 215
Burst Container or Vessel 199 199
Disconnection 182 182
Kinked 166 166
Material Twisted/Bent 158 158
Material Split, Cut or Torn 142 142
Material Separation 142 142
Crack 132 132
Material Puncture/Hole 129 129
Device Operates Differently Than Expected 119 119
Improper or Incorrect Procedure or Method 115 115
Unintended Deflation 106 106
Fracture 99 99
Use of Device Problem 96 96
Migration 92 92
Appropriate Term/Code Not Available 84 84
Human-Device Interface Problem 84 84
Knotted 79 79
Hole In Material 78 78
Material Integrity Problem 78 78
Patient Device Interaction Problem 76 76
Torn Material 74 74
Complete Blockage 74 74
Difficult to Advance 70 70
Component Missing 65 65
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
Defective Device 46 46
Device Handling Problem 46 46
Loose or Intermittent Connection 46 46
Positioning Problem 42 42
Material Perforation 41 41
Partial Blockage 40 40
Material Deformation 34 34
Fitting Problem 33 33
Physical Resistance/Sticking 32 32
Split 29 29
Product Quality Problem 29 29
Difficult to Insert 29 29
No Display/Image 28 28
Stretched 27 27
Biocompatibility 27 27
Pressure Problem 25 25
Loss of or Failure to Bond 25 25
Component Falling 25 25
Contamination 24 24
Inability to Irrigate 24 24
Difficult to Open or Close 23 23
Device Markings/Labelling Problem 21 21
Connection Problem 21 21
Device Displays Incorrect Message 21 21
Separation Failure 20 20
Mechanical Problem 20 20
Off-Label Use 20 20
Decrease in Pressure 20 20
Nonstandard Device 18 18
Material Too Rigid or Stiff 18 18
Retraction Problem 17 17
Misconnection 17 17
Device Damaged Prior to Use 17 17
Difficult to Flush 17 17
Therapeutic or Diagnostic Output Failure 17 17
Device Abrasion From Instrument Or Another Object 16 16
Degraded 16 16
Material Frayed 15 15
Device Slipped 15 15
Device Fell 15 15
Physical Resistance 14 14
Insufficient Flow or Under Infusion 14 14
Loss of Power 14 14
Device Inoperable 13 13
Inadequacy of Device Shape and/or Size 12 12
Restricted Flow rate 12 12
Display or Visual Feedback Problem 12 12
Air Leak 12 12
Deformation Due to Compressive Stress 12 12
No Flow 12 12
Difficult or Delayed Separation 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Positioning Failure 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2426 2427
Unspecified Infection 2016 2016
No Consequences Or Impact To Patient 1791 1791
No Clinical Signs, Symptoms or Conditions 1656 1656
Skin Infection 1631 1708
No Code Available 1183 1183
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 890 917
Post Operative Wound Infection 485 485
Foreign Body In Patient 477 477
Ulcer 378 378
No Information 365 365
Insufficient Information 342 342
Peritonitis 333 333
Pneumothorax 314 314
No Patient Involvement 300 300
Death 270 270
Hemorrhage/Bleeding 260 261
Bowel Perforation 239 239
Pneumonia 197 197
Perforation 183 183
Pressure Sores 158 158
Pain 155 155
Aspiration/Inhalation 128 128
Abscess 117 117
Abdominal Pain 107 107
Sepsis 107 107
Stomach Ulceration 100 100
Tissue Damage 95 95
Device Embedded In Tissue or Plaque 91 91
Blood Loss 85 85
Tissue Breakdown 72 72
Obstruction/Occlusion 71 71
Vomiting 71 71
Discomfort 68 68
Aspiration Pneumonitis 63 63
Laceration(s) 59 59
Injury 58 58
Inflammation 54 54
Ulceration 52 53
Gastrointestinal Hemorrhage 51 52
Feeding Problem 46 46
Erosion 45 45
Necrosis 45 45
Fistula 43 43
Skin Tears 40 40
Skin Inflammation/ Irritation 39 39
Skin Erosion 39 39
Internal Organ Perforation 37 38
Granuloma 36 36
Cellulitis 33 33
Fever 32 32
Erythema 31 31
Failure of Implant 30 30
Fluid Discharge 30 30
Perforation of Esophagus 30 30
Diarrhea 29 29
Respiratory Distress 28 28
Low Oxygen Saturation 28 28
Bacterial Infection 27 27
Skin Irritation 26 26
Patient Problem/Medical Problem 25 25
Abdominal Distention 25 25
Low Blood Pressure/ Hypotension 24 25
Cardiac Arrest 24 24
Anemia 24 24
Laceration(s) of Esophagus 22 22
Needle Stick/Puncture 21 21
Nausea 21 21
Dyspnea 20 20
Incontinence 19 19
Gastritis 17 17
Burn(s) 17 17
Respiratory Failure 17 17
Skin Inflammation 16 16
Fungal Infection 16 16
Unspecified Tissue Injury 16 16
Hypoglycemia 16 16
Pleural Effusion 16 16
Weight Changes 14 14
Tachycardia 13 13
Septic Shock 12 12
Hypoxia 12 12
Skin Discoloration 10 10
Pulmonary Embolism 10 10
Purulent Discharge 10 10
Cough 10 10
Complaint, Ill-Defined 9 9
Hematoma 9 9
Exposure to Body Fluids 8 8
Cardiopulmonary Arrest 8 8
Swelling 8 8
Distress 8 8
Discharge 8 8
Swelling/ Edema 8 8
Reaction 7 7
Drug Resistant Bacterial Infection 6 6
Unintended Extubation 6 6
Constipation 6 6
Not Applicable 6 6
Shock 6 6

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