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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 1417 1417

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 875 875
Leak/Splash 663 663
Gas/Air Leak 622 622
Use of Device Problem 581 581
Defective Component 283 283
Break 276 276
Material Split, Cut or Torn 240 240
Disconnection 149 149
Crack 128 128
Fluid/Blood Leak 117 117
Defective Device 114 114
Material Integrity Problem 105 105
Connection Problem 101 101
Inadequacy of Device Shape and/or Size 97 97
Material Puncture/Hole 96 96
Material Separation 94 94
Detachment of Device or Device Component 85 85
Human-Device Interface Problem 78 78
Air Leak 77 77
Appropriate Term/Code Not Available 66 66
Insufficient Information 59 59
Material Discolored 59 59
Obstruction of Flow 56 56
Fracture 55 55
Deflation Problem 53 53
Material Rupture 51 51
Mechanical Problem 51 51
Material Fragmentation 49 49
Device Markings/Labelling Problem 48 48
Product Quality Problem 47 47
Physical Resistance/Sticking 41 41
Material Deformation 40 40
Patient Device Interaction Problem 39 39
Output Problem 37 37
Labelling, Instructions for Use or Training Problem 36 36
Patient-Device Incompatibility 34 34
Component Missing 33 33
Tear, Rip or Hole in Device Packaging 31 31
Hole In Material 31 31
Burst Container or Vessel 31 31
Deformation Due to Compressive Stress 29 29
Manufacturing, Packaging or Shipping Problem 27 27
Loose or Intermittent Connection 24 24
Gel Leak 23 23
Difficult to Advance 23 23
Device Dislodged or Dislocated 22 22
Failure to Disconnect 22 22
Fitting Problem 21 21
Split 21 21
Contamination /Decontamination Problem 21 21
Adverse Event Without Identified Device or Use Problem 21 21
No Apparent Adverse Event 21 21
Difficult to Remove 20 20
Infusion or Flow Problem 19 19
Decrease in Pressure 18 18
Pressure Problem 18 18
Suction Problem 15 15
Partial Blockage 14 14
Separation Problem 14 14
Noise, Audible 14 14
Positioning Problem 13 13
Failure to Unfold or Unwrap 13 13
Fungus in Device Environment 13 13
Improper or Incorrect Procedure or Method 12 12
Device Contaminated During Manufacture or Shipping 12 12
Device Alarm System 12 12
Contamination 12 12
Degraded 12 12
Material Twisted/Bent 12 12
Torn Material 12 12
Sharp Edges 12 12
Device Contaminated at the User Facility 12 12
Scratched Material 11 11
Packaging Problem 11 11
Difficult to Insert 11 11
Occlusion Within Device 11 11
Material Perforation 11 11
Separation Failure 11 11
Device Operates Differently Than Expected 10 10
Malposition of Device 10 10
Material Too Rigid or Stiff 10 10
Naturally Worn 10 10
Incomplete or Inadequate Connection 10 10
Material Too Soft/Flexible 10 10
Material Protrusion/Extrusion 8 8
Peeled/Delaminated 8 8
Contamination of Device Ingredient or Reagent 8 8
Installation-Related Problem 8 8
Structural Problem 8 8
Device Damaged Prior to Use 8 8
Failure to Advance 7 7
Cut In Material 7 7
Filling Problem 7 7
Short Fill 6 6
Failure to Align 6 6
Volume Accuracy Problem 6 6
Difficult to Open or Close 6 6
Activation, Positioning or Separation Problem 6 6
Unintended Movement 6 6
Suction Failure 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1417 1417
No Consequences Or Impact To Patient 1138 1138
No Known Impact Or Consequence To Patient 618 618
Unintended Extubation 605 605
Extubate 458 458
Insufficient Information 347 347
No Information 264 264
No Patient Involvement 246 246
Low Oxygen Saturation 135 135
No Code Available 77 77
Respiratory Distress 61 61
Airway Obstruction 50 50
Death 50 50
Decreased Respiratory Rate 45 45
Hypoxia 43 43
Hypoventilation 42 42
Dyspnea 41 41
Blood Loss 36 36
Unspecified Tissue Injury 34 34
Pain 32 32
Discomfort 30 30
Hemorrhage/Bleeding 28 28
Injury 27 27
Irritation 18 18
Tachycardia 18 18
Aspiration/Inhalation 16 16
Cardiac Arrest 15 15
Hemoptysis 14 14
Inflammation 14 14
Unspecified Infection 13 13
Ventilator Dependent 12 12
Distress 12 12
Skin Inflammation/ Irritation 11 11
Pneumothorax 11 11
Bradycardia 9 9
Respiratory Insufficiency 9 9
Respiratory Failure 9 9
Obstruction/Occlusion 9 9
Anxiety 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Patient Problem/Medical Problem 8 8
Granuloma 8 8
Dysphasia 8 8
Pneumonia 8 8
Cyanosis 7 7
Unspecified Respiratory Problem 7 7
Respiratory Tract Infection 7 7
Increased Respiratory Rate 7 7
Sudden Cardiac Death 6 6
Pressure Sores 6 6
Foreign Body In Patient 6 6
Fistula 6 6
Asphyxia 6 6
Erythema 5 5
Skin Irritation 5 5
Laceration(s) 5 5
Stenosis 5 5
Ulcer 4 4
Bronchospasm 4 4
Forced Expiratory Volume Decreased 4 4
Swelling 4 4
Pulmonary Emphysema 4 4
Dysphagia/ Odynophagia 4 4
Low Blood Pressure/ Hypotension 4 4
Bacterial Infection 4 4
Wound Dehiscence 4 4
Cardiopulmonary Arrest 3 3
Hypersensitivity/Allergic reaction 3 3
Hyperventilation 3 3
Pleural Effusion 3 3
Respiratory Acidosis 3 3
Irritability 3 3
Complaint, Ill-Defined 3 3
Missing Value Reason 3 3
Cardiovascular Insufficiency 3 3
Localized Skin Lesion 3 3
Not Applicable 2 2
Convulsion/Seizure 2 2
Tissue Breakdown 2 2
Fluid Discharge 2 2
Loss of consciousness 2 2
Skin Tears 2 2
Lethargy 2 2
Rash 2 2
Local Reaction 2 2
Infiltration into Tissue 2 2
Suffocation 2 2
Scar Tissue 2 2
Electrolyte Imbalance 2 2
Ulceration 2 2
Ventricular Fibrillation 2 2
Foreign Body Reaction 2 2
Exposure to Body Fluids 2 2
Abrasion 2 2
Asthma 2 2
Apnea 2 2
Atrial Fibrillation 1 1
Adult Respiratory Distress Syndrome 1 1
Air Embolism 1 1
Erosion 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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