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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

MDR Year MDR Reports MDR Events
2019 1019 1019
2020 791 791
2021 1041 1041
2022 1633 1633
2023 1233 1233
2024 352 352

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 995 995
Use of Device Problem 898 898
Inflation Problem 854 854
Leak/Splash 505 505
Defective Component 391 391
Material Split, Cut or Torn 340 340
Break 238 238
Connection Problem 216 216
Disconnection 151 151
Crack 135 135
Defective Device 123 123
Material Separation 115 115
Fluid/Blood Leak 114 114
Material Puncture/Hole 110 110
Appropriate Term/Code Not Available 92 92
Fracture 91 91
Insufficient Information 88 88
Detachment of Device or Device Component 85 85
Inadequacy of Device Shape and/or Size 77 77
Physical Resistance/Sticking 76 76
Human-Device Interface Problem 71 71
Material Discolored 67 67
Obstruction of Flow 66 66
Material Integrity Problem 59 59
Device Markings/Labelling Problem 52 52
Deflation Problem 52 52
Material Fragmentation 50 50
Material Rupture 48 48
Labelling, Instructions for Use or Training Problem 45 45
Patient-Device Incompatibility 43 43
Patient Device Interaction Problem 43 43
Mechanical Problem 42 42
Component Missing 34 34
Contamination 33 33
Material Deformation 31 31
Adverse Event Without Identified Device or Use Problem 30 30
Product Quality Problem 29 29
Unintended Deflation 27 27
Difficult to Advance 26 26
Tear, Rip or Hole in Device Packaging 26 26
Deformation Due to Compressive Stress 24 24
Contamination /Decontamination Problem 22 22
Difficult to Insert 21 21
No Apparent Adverse Event 21 21
Gel Leak 20 20
Material Twisted/Bent 19 19
Loose or Intermittent Connection 18 18
Difficult to Remove 18 18
Separation Problem 18 18
Microbial Contamination of Device 17 17
Fitting Problem 16 16
Device-Device Incompatibility 16 16
Device Dislodged or Dislocated 16 16
Output Problem 16 16
Pressure Problem 15 15
Infusion or Flow Problem 14 14
Failure to Unfold or Unwrap 14 14
Partial Blockage 14 14
Degraded 13 13
Suction Problem 13 13
Fungus in Device Environment 13 13
Device Contaminated During Manufacture or Shipping 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Device Contaminated at the User Facility 12 12
Material Too Soft/Flexible 11 11
Incomplete or Inadequate Connection 11 11
Improper or Incorrect Procedure or Method 11 11
Nonstandard Device 11 11
Decrease in Pressure 10 10
Device Alarm System 10 10
Failure to Deflate 10 10
Failure to Seal 9 9
Burst Container or Vessel 9 9
Structural Problem 9 9
Installation-Related Problem 9 9
Malposition of Device 8 8
Scratched Material 8 8
Separation Failure 8 8
Device Damaged Prior to Use 8 8
Filling Problem 8 8
Material Too Rigid or Stiff 8 8
Stretched 7 7
Complete Blockage 7 7
Volume Accuracy Problem 6 6
Short Fill 6 6
Peeled/Delaminated 6 6
Material Perforation 6 6
Optical Discoloration 6 6
Material Protrusion/Extrusion 6 6
Fail-Safe Did Not Operate 6 6
Unexpected Color 6 6
Sharp Edges 6 6
Packaging Problem 5 5
Noise, Audible 5 5
Missing Information 5 5
Therapeutic or Diagnostic Output Failure 5 5
Unintended Movement 5 5
Contamination of Device Ingredient or Reagent 5 5
Activation, Positioning or Separation Problem 5 5
Overfill 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2309 2309
Unintended Extubation 1134 1134
No Consequences Or Impact To Patient 815 815
Insufficient Information 655 655
Extubate 264 264
No Information 217 217
No Known Impact Or Consequence To Patient 207 207
Low Oxygen Saturation 162 162
No Patient Involvement 147 147
Hypoventilation 88 88
Decreased Respiratory Rate 78 78
Airway Obstruction 59 59
No Code Available 54 54
Unspecified Tissue Injury 54 54
Dyspnea 52 52
Respiratory Insufficiency 44 44
Hemorrhage/Bleeding 42 42
Respiratory Distress 39 39
Hypoxia 35 35
Death 31 31
Pain 29 29
Discomfort 28 28
Tachycardia 23 23
Skin Inflammation/ Irritation 21 21
Cardiac Arrest 18 18
Inflammation 17 17
Irritation 16 16
Aspiration/Inhalation 15 15
Respiratory Failure 15 15
Distress 15 15
Injury 14 14
Unspecified Infection 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Unspecified Respiratory Problem 12 12
Pneumothorax 12 12
Pneumonia 11 11
Foreign Body In Patient 11 11
Failure of Implant 9 9
Bradycardia 9 9
Respiratory Tract Infection 8 8
Pressure Sores 8 8
Dysphasia 8 8
Anxiety 7 7
Increased Respiratory Rate 7 7
Obstruction/Occlusion 7 7
Stenosis 6 6
Ventilator Dependent 6 6
Sore Throat 6 6
Cough 6 6
Bacterial Infection 6 6
Hemoptysis 6 6
Fistula 6 6
Cyanosis 6 6
Dysphagia/ Odynophagia 5 5
Granuloma 5 5
Wound Dehiscence 5 5
Low Blood Pressure/ Hypotension 5 5
Patient Problem/Medical Problem 5 5
Swelling/ Edema 5 5
Ulcer 5 5
Irritability 4 4
Forced Expiratory Volume Decreased 4 4
Cardiovascular Insufficiency 4 4
Laceration(s) 4 4
Apnea 4 4
Chest Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Asphyxia 4 4
Pulmonary Emphysema 4 4
Erythema 4 4
Hyperventilation 3 3
Skin Irritation 3 3
Respiratory Arrest 3 3
Tissue Breakdown 3 3
Device Embedded In Tissue or Plaque 3 3
Localized Skin Lesion 3 3
Respiratory Acidosis 3 3
Sudden Cardiac Death 3 3
Blood Loss 3 3
Skin Tears 2 2
Choking 2 2
Local Reaction 2 2
Viral Infection 2 2
Unintended Radiation Exposure 2 2
Fluid Discharge 2 2
Unspecified Heart Problem 2 2
Convulsion/Seizure 2 2
Swelling 2 2
Respiratory Distress Syndrome of Newborns 2 2
Pulmonary Edema 2 2
Ventricular Fibrillation 2 2
Perforation 2 2
Pleural Effusion 2 2
Fatigue 2 2
High Blood Pressure/ Hypertension 2 2
Asthma 2 2
Abrasion 2 2
Abscess 1 1
Adult Respiratory Distress Syndrome 1 1
Air Embolism 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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