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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 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRACOE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 441 441
2018 810 810
2019 1019 1019
2020 791 791
2021 1053 1053
2022 461 461

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 685 685
Leak/Splash 632 632
Gas Leak 484 484
Use of Device Problem 466 466
Break 233 233
Material Split, Cut or Torn 211 211
Defective Component 205 205
Disconnection 139 139
Crack 115 115
Fluid Leak 108 108
Material Integrity Problem 105 105
Inadequacy of Device Shape and/or Size 91 91
Material Puncture/Hole 80 80
Air Leak 77 77
Material Separation 76 76
Detachment of Device or Device Component 76 76
Defective Device 64 64
Human-Device Interface Problem 62 62
Connection Problem 60 60
Material Discolored 58 58
Appropriate Term/Code Not Available 55 55
Fracture 50 50
Material Rupture 50 50
Material Fragmentation 48 48
Deflation Problem 47 47
Mechanical Problem 47 47
Insufficient Information 43 43
Obstruction of Flow 41 41
Product Quality Problem 37 37
Output Problem 36 36
Material Deformation 33 33
Hole In Material 31 31
Burst Container or Vessel 31 31
Patient-Device Incompatibility 29 29
Deformation Due to Compressive Stress 25 25
Tear, Rip or Hole in Device Packaging 25 25
Component Missing 25 25
Manufacturing, Packaging or Shipping Problem 23 23
Device Markings/Labelling Problem 23 23
Physical Resistance/Sticking 23 23
Device Dislodged or Dislocated 22 22
Failure to Disconnect 22 22
Gel Leak 22 22
Loose or Intermittent Connection 22 22
Split 21 21
Adverse Event Without Identified Device or Use Problem 21 21
Infusion or Flow Problem 19 19
Difficult to Advance 19 19
Patient Device Interaction Problem 19 19
Pressure Problem 18 18
Decrease in Pressure 18 18
Difficult to Remove 17 17
Labelling, Instructions for Use or Training Problem 17 17
Contamination /Decontamination Problem 15 15
Suction Problem 15 15
Fitting Problem 15 15
Partial Blockage 14 14
Positioning Problem 13 13
Torn Material 12 12
Device Alarm System 12 12
Fungus in Device Environment 12 12
Improper or Incorrect Procedure or Method 11 11
Failure to Unfold or Unwrap 11 11
Separation Failure 11 11
Occlusion Within Device 11 11
Scratched Material 11 11
Noise, Audible 11 11
Separation Problem 10 10
Malposition of Device 10 10
Device Operates Differently Than Expected 10 10
Device Contaminated During Manufacture or Shipping 10 10
Naturally Worn 10 10
Material Twisted/Bent 10 10
Packaging Problem 9 9
Sharp Edges 8 8
Contamination of Device Ingredient or Reagent 8 8
Structural Problem 8 8
Contamination 8 8
Peeled/Delaminated 7 7
Material Too Rigid or Stiff 7 7
Failure to Advance 7 7
Material Perforation 7 7
Cut In Material 7 7
Installation-Related Problem 7 7
Activation, Positioning or SeparationProblem 6 6
Difficult to Open or Close 6 6
Device Damaged Prior to Use 6 6
Failure to Align 6 6
Degraded 6 6
Suction Failure 6 6
Fail-Safe Did Not Operate 6 6
Unintended Movement 6 6
Optical Discoloration 5 5
Premature Separation 5 5
Complete Blockage 5 5
False Alarm 5 5
Device Slipped 5 5
Stretched 5 5
Material Opacification 5 5
Difficult to Insert 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1138 1138
No Clinical Signs, Symptoms or Conditions 765 765
No Known Impact Or Consequence To Patient 618 618
Extubate 458 458
Unintended Extubation 409 409
Insufficient Information 286 286
No Information 264 264
No Patient Involvement 246 246
Low Oxygen Saturation 107 107
No Code Available 77 77
Respiratory Distress 61 61
Death 50 50
Airway Obstruction 45 45
Hypoxia 37 37
Blood Loss 36 36
Discomfort 30 30
Pain 28 28
Dyspnea 28 28
Hypoventilation 27 27
Injury 27 27
Unspecified Tissue Injury 24 24
Hemorrhage/Bleeding 19 19
Irritation 18 18
Inflammation 12 12
Tachycardia 12 12
Hemoptysis 12 12
Aspiration/Inhalation 12 12
Cardiac Arrest 11 11
Pneumothorax 10 10
Unspecified Infection 10 10
Distress 10 10
Ventilator Dependent 10 10
Anxiety 8 8
Respiratory Failure 8 8
Patient Problem/Medical Problem 8 8
Respiratory Insufficiency 8 8
Dysphasia 8 8
Pneumonia 7 7
Granuloma 7 7
Obstruction/Occlusion 7 7
Sudden Cardiac Death 6 6
Skin Inflammation/ Irritation 6 6
Fistula 6 6
Asphyxia 6 6
Bradycardia 5 5
Cyanosis 5 5
Laceration(s) 5 5
Skin Irritation 5 5
Unspecified Respiratory Problem 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Increased Respiratory Rate 5 5
Foreign Body In Patient 5 5
Pressure Sores 5 5
Bronchospasm 4 4
Swelling 4 4
Low Blood Pressure/ Hypotension 4 4
Erythema 4 4
Dysphagia/ Odynophagia 4 4
Hyperventilation 3 3
Pulmonary Emphysema 3 3
Cardiopulmonary Arrest 3 3
Bacterial Infection 3 3
Wound Dehiscence 3 3
Pleural Effusion 3 3
Decreased Respiratory Rate 3 3
Respiratory Acidosis 3 3
Ulcer 3 3
Complaint, Ill-Defined 3 3
Respiratory Tract Infection 3 3
Missing Value Reason 3 3
Convulsion/Seizure 2 2
Fluid Discharge 2 2
Not Applicable 2 2
Loss of consciousness 2 2
Stenosis 2 2
Skin Tears 2 2
Lethargy 2 2
Infiltration into Tissue 2 2
Local Reaction 2 2
Suffocation 2 2
Scar Tissue 2 2
Electrolyte Imbalance 2 2
Ulceration 2 2
Asthma 2 2
Apnea 2 2
Exposure to Body Fluids 2 2
Hypersensitivity/Allergic reaction 2 2
Foreign Body Reaction 2 2
Encephalopathy 1 1
Endocarditis 1 1
Non specific EKG/ECG Changes 1 1
Macular Edema 1 1
Fatigue 1 1
Fever 1 1
Purulent Discharge 1 1
Atrial Fibrillation 1 1
Abrasion 1 1
Adult Respiratory Distress Syndrome 1 1
Air Embolism 1 1
Ventricular Fibrillation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Jul-01-2021
2 Smiths Medical ASD Inc. II Feb-23-2021
3 Smiths Medical ASD Inc. II Dec-28-2020
4 Smiths Medical ASD Inc. II Sep-09-2020
5 Smiths Medical ASD Inc. II Jul-01-2020
6 Smiths Medical ASD Inc. II Sep-26-2017
7 Smiths Medical ASD Inc. II Mar-14-2017
8 Smiths Medical ASD, Inc. II Feb-09-2018
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