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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
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 3
ASPIRE BARIATRICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ASPIRE BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONIX DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN (DBA MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSYS INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 3
WELL LEAD MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 2

MDR Year MDR Reports MDR Events
2017 1672 1672
2018 1899 1899
2019 1837 1837
2020 1641 1641
2021 1652 1652

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4021 4021
Fluid Leak 629 629
Break 529 529
Insufficient Information 465 465
Leak/Splash 439 439
Detachment of Device or Device Component 430 430
Difficult to Remove 179 179
Detachment Of Device Component 167 167
Malposition of Device 159 159
Deflation Problem 154 154
Device Dislodged or Dislocated 134 134
Disconnection 124 124
Material Rupture 111 111
Material Twisted/Bent 105 105
Obstruction of Flow 104 104
Crack 86 86
Migration or Expulsion of Device 82 82
Material Split, Cut or Torn 82 82
Kinked 80 80
Inflation Problem 76 76
Material Puncture/Hole 76 76
Migration 74 74
Occlusion Within Device 70 70
Burst Container or Vessel 61 61
Material Separation 60 60
Fracture 58 58
Appropriate Term/Code Not Available 54 54
Complete Blockage 50 50
Use of Device Problem 39 39
Device Contamination with Chemical or Other Material 39 39
Component Missing 38 38
Improper or Incorrect Procedure or Method 37 37
Patient-Device Incompatibility 37 37
Device Operates Differently Than Expected 37 37
Patient Device Interaction Problem 36 36
Knotted 35 35
Material Perforation 34 34
Hole In Material 30 30
Difficult to Advance 30 30
No Apparent Adverse Event 29 29
Physical Resistance/Sticking 27 27
Material Fragmentation 27 27
Defective Component 27 27
No Display/Image 24 24
Partial Blockage 23 23
Entrapment of Device 22 22
Loose or Intermittent Connection 21 21
Biocompatibility 21 21
Defective Device 21 21
Positioning Problem 21 21
Material Integrity Problem 20 20
Material Deformation 19 19
Pressure Problem 19 19
Fitting Problem 19 19
Component Falling 16 16
Difficult to Open or Close 15 15
Device Fell 15 15
Device Handling Problem 15 15
Torn Material 14 14
Human-Device Interface Problem 14 14
Material Frayed 14 14
Split 14 14
Degraded 13 13
Device Displays Incorrect Message 11 11
Device Markings/Labelling Problem 11 11
Retraction Problem 10 10
Product Quality Problem 10 10
Loss of Power 10 10
Therapeutic or Diagnostic Output Failure 10 10
No Flow 9 9
Difficult to Insert 9 9
Positioning Failure 9 9
Decrease in Pressure 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Off-Label Use 8 8
Separation Failure 8 8
Difficult to Flush 8 8
Nonstandard Device 8 8
Display or Visual Feedback Problem 7 7
Difficult or Delayed Positioning 7 7
Deformation Due to Compressive Stress 7 7
Suction Problem 7 7
Device Slipped 7 7
Gas Leak 7 7
Device Contaminated During Manufacture or Shipping 7 7
Stretched 6 6
Inadequacy of Device Shape and/or Size 6 6
Insufficient Flow or Under Infusion 6 6
Contamination /Decontamination Problem 6 6
Connection Problem 6 6
Material Discolored 6 6
No Audible Alarm 6 6
Mechanical Problem 6 6
Misconnection 5 5
Flushing Problem 5 5
Loss of or Failure to Bond 5 5
Contamination 5 5
Coiled 5 5
Physical Resistance 5 5
Structural Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1695 1695
No Consequences Or Impact To Patient 1321 1321
No Known Impact Or Consequence To Patient 1168 1168
No Code Available 1016 1016
No Clinical Signs, Symptoms or Conditions 434 434
Post Operative Wound Infection 431 431
Skin Infection 426 426
Ulcer 273 273
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 257 257
No Patient Involvement 234 234
Peritonitis 213 213
Death 188 188
Foreign Body In Patient 162 162
No Information 162 162
Pneumothorax 156 156
Pneumonia 150 150
Hemorrhage/Bleeding 142 142
Insufficient Information 127 127
Bowel Perforation 113 113
Perforation 110 110
Aspiration/Inhalation 87 87
Pain 83 83
Abscess 80 80
Device Embedded In Tissue or Plaque 63 63
Sepsis 59 59
Pressure Sores 59 59
Abdominal Pain 49 49
Obstruction/Occlusion 48 48
Inflammation 44 44
Vomiting 43 43
Tissue Damage 41 41
Injury 40 40
Tissue Breakdown 37 37
Discomfort 36 36
Blood Loss 31 31
Internal Organ Perforation 29 30
Ulceration 27 27
Fistula 26 26
Granuloma 22 22
Laceration(s) 22 22
Patient Problem/Medical Problem 22 22
Cellulitis 20 20
Necrosis 19 19
Perforation of Esophagus 19 19
Respiratory Distress 16 16
Cardiac Arrest 16 16
Bacterial Infection 16 16
Erosion 15 15
Skin Irritation 15 15
Fever 14 14
Erythema 14 14
Feeding Problem 13 13
Anemia 13 13
Stomach Ulceration 13 13
Low Oxygen Saturation 13 13
Gastrointestinal Hemorrhage 12 12
Low Blood Pressure/ Hypotension 12 12
Pleural Effusion 11 11
Nausea 11 11
Aspiration Pneumonitis 11 11
Abdominal Distention 11 11
Diarrhea 10 10
Burn(s) 10 10
Dyspnea 9 9
Gastritis 9 9
Tachycardia 9 9
Respiratory Failure 9 9
Needle Stick/Puncture 9 9
Skin Inflammation 8 8
Weight Changes 8 8
Skin Erosion 8 8
Septic Shock 8 8
Hypoglycemia 8 8
Hematoma 7 7
Hypoxia 7 7
Pulmonary Embolism 7 7
Failure of Implant 6 6
Adult Respiratory Distress Syndrome 5 5
Laceration(s) of Esophagus 5 5
Rupture 5 5
Skin Tears 5 5
Fungal Infection 5 5
Skin Inflammation/ Irritation 5 5
Unspecified Tissue Injury 4 4
Cough 4 4
Fluid Discharge 4 4
Underdose 4 4
Renal Failure 4 4
Thrombus 4 4
Swelling 4 4
Exposure to Body Fluids 4 4
Edema 4 4
Incontinence 4 4
Hypersensitivity/Allergic reaction 4 4
Hemothorax 3 3
Hyperemia 3 3
Purulent Discharge 3 3
Headache 3 3
Cardiopulmonary Arrest 3 3
Chest Pain 3 3

Recalls
Manufacturer Recall Class Date Posted
1 AbbVie Inc. II May-31-2017
2 Applied Medical Technology Inc III Feb-17-2017
3 Avanos Medical, Inc. II Dec-07-2020
4 Avanos Medical, Inc. II Sep-17-2020
5 Avanos Medical, Inc. II Nov-14-2019
6 CORPAK MedSystems, Inc. II May-25-2017
7 COVIDIEN LLC II Dec-11-2018
8 Cook Inc. II Mar-01-2018
9 Covidien LLC II Feb-20-2018
10 Hollister Incorporated II Mar-26-2021
11 Neomed Inc III Nov-30-2018
12 Teleflex Medical Europe Ltd II Apr-12-2018
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