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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube tracheostomy and tube cuff
Product CodeJOH
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRACOE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K203362  TRACOE vario

MDR Year MDR Reports MDR Events
2019 1019 1019
2020 791 791
2021 1041 1041
2022 1633 1633
2023 1233 1233
2024 243 243

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 972 972
Use of Device Problem 876 876
Inflation Problem 844 844
Leak/Splash 504 504
Defective Component 375 375
Material Split, Cut or Torn 327 327
Break 238 238
Connection Problem 211 211
Disconnection 150 150
Crack 135 135
Defective Device 122 122
Material Separation 115 115
Fluid/Blood Leak 111 111
Material Puncture/Hole 110 110
Appropriate Term/Code Not Available 89 89
Detachment of Device or Device Component 85 85
Insufficient Information 84 84
Fracture 82 82
Physical Resistance/Sticking 76 76
Inadequacy of Device Shape and/or Size 75 75
Human-Device Interface Problem 70 70
Material Discolored 67 67
Obstruction of Flow 66 66
Material Integrity Problem 58 58
Device Markings/Labelling Problem 52 52
Deflation Problem 51 51
Material Fragmentation 50 50
Material Rupture 48 48
Labelling, Instructions for Use or Training Problem 45 45
Patient-Device Incompatibility 43 43
Mechanical Problem 42 42
Patient Device Interaction Problem 42 42
Contamination 33 33
Component Missing 32 32
Material Deformation 31 31
Adverse Event Without Identified Device or Use Problem 30 30
Product Quality Problem 29 29
Tear, Rip or Hole in Device Packaging 26 26
Difficult to Advance 26 26
Unintended Deflation 25 25
Deformation Due to Compressive Stress 24 24
No Apparent Adverse Event 21 21
Contamination /Decontamination Problem 21 21
Difficult to Insert 21 21
Gel Leak 20 20
Separation Problem 18 18
Loose or Intermittent Connection 18 18
Difficult to Remove 18 18
Material Twisted/Bent 18 18
Microbial Contamination of Device 17 17
Output Problem 16 16
Fitting Problem 16 16
Device Dislodged or Dislocated 16 16
Pressure Problem 15 15
Device-Device Incompatibility 15 15
Failure to Unfold or Unwrap 14 14
Infusion or Flow Problem 14 14
Suction Problem 13 13
Degraded 13 13
Fungus in Device Environment 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Partial Blockage 12 12
Device Contaminated During Manufacture or Shipping 12 12
Device Contaminated at the User Facility 12 12
Improper or Incorrect Procedure or Method 11 11
Incomplete or Inadequate Connection 11 11
Nonstandard Device 11 11
Material Too Soft/Flexible 11 11
Failure to Deflate 10 10
Device Alarm System 10 10
Decrease in Pressure 10 10
Installation-Related Problem 9 9
Failure to Seal 9 9
Structural Problem 8 8
Burst Container or Vessel 8 8
Separation Failure 8 8
Material Too Rigid or Stiff 8 8
Device Damaged Prior to Use 8 8
Scratched Material 8 8
Malposition of Device 8 8
Filling Problem 8 8
Stretched 7 7
Complete Blockage 7 7
Material Protrusion/Extrusion 6 6
Unexpected Color 6 6
Peeled/Delaminated 6 6
Material Perforation 6 6
Sharp Edges 6 6
Volume Accuracy Problem 6 6
Short Fill 6 6
Optical Discoloration 6 6
Fail-Safe Did Not Operate 6 6
Missing Information 5 5
Therapeutic or Diagnostic Output Failure 5 5
Activation, Positioning or Separation Problem 5 5
Overfill 5 5
Tidal Volume Fluctuations 5 5
Noise, Audible 5 5
Packaging Problem 5 5
Contamination of Device Ingredient or Reagent 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2252 2252
Unintended Extubation 1093 1093
No Consequences Or Impact To Patient 815 815
Insufficient Information 645 645
Extubate 264 264
No Information 217 217
No Known Impact Or Consequence To Patient 207 207
Low Oxygen Saturation 158 158
No Patient Involvement 147 147
Hypoventilation 80 80
Decreased Respiratory Rate 77 77
Airway Obstruction 59 59
No Code Available 54 54
Unspecified Tissue Injury 51 51
Dyspnea 51 51
Respiratory Insufficiency 41 41
Hemorrhage/Bleeding 40 40
Respiratory Distress 39 39
Hypoxia 35 35
Death 31 31
Pain 28 28
Discomfort 28 28
Tachycardia 23 23
Skin Inflammation/ Irritation 20 20
Cardiac Arrest 18 18
Inflammation 17 17
Irritation 16 16
Respiratory Failure 15 15
Distress 15 15
Unspecified Infection 14 14
Injury 14 14
Aspiration/Inhalation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Pneumothorax 12 12
Unspecified Respiratory Problem 12 12
Pneumonia 11 11
Failure of Implant 9 9
Foreign Body In Patient 9 9
Bradycardia 9 9
Dysphasia 8 8
Pressure Sores 8 8
Respiratory Tract Infection 8 8
Obstruction/Occlusion 7 7
Increased Respiratory Rate 7 7
Anxiety 7 7
Hemoptysis 6 6
Cyanosis 6 6
Bacterial Infection 6 6
Fistula 6 6
Granuloma 5 5
Wound Dehiscence 5 5
Dysphagia/ Odynophagia 5 5
Patient Problem/Medical Problem 5 5
Swelling/ Edema 5 5
Ventilator Dependent 5 5
Stenosis 5 5
Cough 5 5
Ulcer 5 5
Laceration(s) 4 4
Sore Throat 4 4
Pulmonary Emphysema 4 4
Asphyxia 4 4
Irritability 4 4
Apnea 4 4
Cardiovascular Insufficiency 4 4
Hypersensitivity/Allergic reaction 4 4
Low Blood Pressure/ Hypotension 4 4
Erythema 4 4
Chest Pain 4 4
Forced Expiratory Volume Decreased 4 4
Blood Loss 3 3
Skin Irritation 3 3
Respiratory Acidosis 3 3
Localized Skin Lesion 3 3
Respiratory Arrest 3 3
Hyperventilation 3 3
Tissue Breakdown 3 3
Sudden Cardiac Death 3 3
Fatigue 2 2
Respiratory Distress Syndrome of Newborns 2 2
Choking 2 2
Pleural Effusion 2 2
Convulsion/Seizure 2 2
Abrasion 2 2
Swelling 2 2
Unintended Radiation Exposure 2 2
Unspecified Heart Problem 2 2
Fluid Discharge 2 2
Viral Infection 2 2
Skin Tears 2 2
Local Reaction 2 2
Pulmonary Edema 2 2
Perforation 2 2
High Blood Pressure/ Hypertension 2 2
Ventricular Fibrillation 2 2
Asthma 2 2
Device Embedded In Tissue or Plaque 2 2
Itching Sensation 1 1
Vomiting 1 1
Purulent Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Incorporated I May-10-2023
2 Covidien I Apr-19-2023
3 Smiths Medical ASD Inc. II Oct-31-2023
4 Smiths Medical ASD Inc. II Jul-01-2021
5 Smiths Medical ASD Inc. II Feb-23-2021
6 Smiths Medical ASD Inc. II Dec-28-2020
7 Smiths Medical ASD Inc. II Sep-09-2020
8 Smiths Medical ASD Inc. II Jul-01-2020
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