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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 422 422

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 999 999
Use of Device Problem 923 923
Inflation Problem 864 864
Leak/Splash 505 505
Defective Component 393 393
Material Split, Cut or Torn 343 343
Break 240 240
Connection Problem 216 216
Disconnection 151 151
Crack 137 137
Defective Device 124 124
Material Separation 117 117
Fluid/Blood Leak 116 116
Material Puncture/Hole 111 111
Appropriate Term/Code Not Available 94 94
Fracture 93 93
Insufficient Information 89 89
Detachment of Device or Device Component 88 88
Inadequacy of Device Shape and/or Size 77 77
Physical Resistance/Sticking 77 77
Human-Device Interface Problem 71 71
Material Discolored 67 67
Obstruction of Flow 66 66
Material Integrity Problem 59 59
Deflation Problem 55 55
Device Markings/Labelling Problem 53 53
Material Fragmentation 50 50
Material Rupture 50 50
Labelling, Instructions for Use or Training Problem 46 46
Mechanical Problem 43 43
Patient-Device Incompatibility 43 43
Patient Device Interaction Problem 43 43
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
Separation Problem 19 19
Loose or Intermittent Connection 18 18
Difficult to Remove 18 18
Device-Device Incompatibility 17 17
Microbial Contamination of Device 17 17
Fitting Problem 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
Device Contaminated During Manufacture or Shipping 13 13
Suction Problem 13 13
Fungus in Device Environment 13 13
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
Structural Problem 10 10
Failure to Deflate 10 10
Failure to Seal 9 9
Installation-Related Problem 9 9
Burst Container or Vessel 9 9
Filling Problem 8 8
Material Too Rigid or Stiff 8 8
Malposition of Device 8 8
Scratched Material 8 8
Separation Failure 8 8
Device Damaged Prior to Use 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 2344 2344
Unintended Extubation 1158 1158
No Consequences Or Impact To Patient 815 815
Insufficient Information 661 661
Extubate 264 264
No Information 217 217
No Known Impact Or Consequence To Patient 207 207
Low Oxygen Saturation 165 165
No Patient Involvement 147 147
Hypoventilation 89 89
Decreased Respiratory Rate 78 78
Airway Obstruction 59 59
Dyspnea 54 54
No Code Available 54 54
Unspecified Tissue Injury 54 54
Respiratory Insufficiency 44 44
Hemorrhage/Bleeding 43 43
Respiratory Distress 39 39
Hypoxia 35 35
Death 31 31
Pain 29 29
Discomfort 28 28
Tachycardia 23 23
Skin Inflammation/ Irritation 22 22
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
Low Blood Pressure/ Hypotension 7 7
Bacterial Infection 6 6
Hemoptysis 6 6
Fistula 6 6
Cyanosis 6 6
Stenosis 6 6
Ventilator Dependent 6 6
Sore Throat 6 6
Cough 6 6
Patient Problem/Medical Problem 5 5
Swelling/ Edema 5 5
Ulcer 5 5
Dysphagia/ Odynophagia 5 5
Granuloma 5 5
Wound Dehiscence 5 5
Apnea 4 4
Chest Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Asphyxia 4 4
Pulmonary Emphysema 4 4
Erythema 4 4
Laceration(s) 4 4
Irritability 4 4
Forced Expiratory Volume Decreased 4 4
Cardiovascular Insufficiency 4 4
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
Hyperventilation 3 3
Skin Irritation 3 3
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
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
Unspecified Blood or Lymphatic problem 1 1
Thrombosis/Thrombus 1 1
Asystole 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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