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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 2
TRACOE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 812 812
2019 1019 1019
2020 791 791
2021 1041 1041
2022 1633 1633
2023 1076 1076

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 990 990
Gas/Air Leak 890 890
Use of Device Problem 759 759
Leak/Splash 627 627
Defective Component 360 360
Material Split, Cut or Torn 341 341
Break 277 277
Connection Problem 211 211
Disconnection 163 163
Crack 137 137
Defective Device 132 132
Material Separation 122 122
Material Puncture/Hole 120 120
Fluid/Blood Leak 112 112
Inadequacy of Device Shape and/or Size 96 96
Detachment of Device or Device Component 92 92
Human-Device Interface Problem 89 89
Fracture 83 83
Appropriate Term/Code Not Available 81 81
Material Integrity Problem 76 76
Obstruction of Flow 74 74
Material Discolored 73 73
Insufficient Information 73 73
Physical Resistance/Sticking 73 73
Deflation Problem 59 59
Material Fragmentation 54 54
Material Rupture 53 53
Product Quality Problem 49 49
Device Markings/Labelling Problem 48 48
Patient-Device Incompatibility 46 46
Mechanical Problem 45 45
Labelling, Instructions for Use or Training Problem 42 42
Patient Device Interaction Problem 42 42
Component Missing 41 41
Air Leak 39 39
Output Problem 37 37
Material Deformation 36 36
Adverse Event Without Identified Device or Use Problem 34 34
Contamination 34 34
Tear, Rip or Hole in Device Packaging 27 27
Deformation Due to Compressive Stress 26 26
Burst Container or Vessel 26 26
Difficult to Advance 25 25
Contamination /Decontamination Problem 24 24
Failure to Disconnect 22 22
Gel Leak 22 22
Difficult to Remove 22 22
Difficult to Insert 21 21
Loose or Intermittent Connection 21 21
Fitting Problem 21 21
No Apparent Adverse Event 21 21
Unintended Deflation 21 21
Pressure Problem 19 19
Suction Problem 19 19
Device Dislodged or Dislocated 19 19
Decrease in Pressure 18 18
Partial Blockage 18 18
Material Twisted/Bent 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Infusion or Flow Problem 16 16
Degraded 15 15
Separation Problem 15 15
Noise, Audible 14 14
Sharp Edges 13 13
Device-Device Incompatibility 13 13
Improper or Incorrect Procedure or Method 13 13
Failure to Unfold or Unwrap 13 13
Microbial Contamination of Device 13 13
Fungus in Device Environment 13 13
Device Contaminated at the User Facility 12 12
Positioning Problem 12 12
Device Contaminated During Manufacture or Shipping 12 12
Material Too Soft/Flexible 11 11
Incomplete or Inadequate Connection 11 11
Device Damaged Prior to Use 11 11
Nonstandard Device 11 11
Device Alarm System 10 10
Split 10 10
Contamination of Device Ingredient or Reagent 10 10
Separation Failure 10 10
Malposition of Device 10 10
Failure to Deflate 10 10
Failure to Seal 9 9
Scratched Material 9 9
Material Protrusion/Extrusion 9 9
Installation-Related Problem 9 9
Occlusion Within Device 9 9
Material Too Rigid or Stiff 8 8
Complete Blockage 8 8
Filling Problem 8 8
Stretched 8 8
Structural Problem 8 8
Peeled/Delaminated 7 7
Failure to Align 6 6
Short Fill 6 6
Material Perforation 6 6
Volume Accuracy Problem 6 6
Improper Flow or Infusion 6 6
Difficult to Open or Close 6 6
Activation, Positioning or Separation Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2051 2051
No Consequences Or Impact To Patient 1014 1014
Unintended Extubation 951 951
Insufficient Information 594 594
No Known Impact Or Consequence To Patient 522 522
Extubate 377 377
No Information 244 244
No Patient Involvement 203 203
Low Oxygen Saturation 154 154
Decreased Respiratory Rate 77 77
No Code Available 72 72
Hypoventilation 67 67
Airway Obstruction 59 59
Respiratory Distress 53 53
Unspecified Tissue Injury 50 50
Hypoxia 46 46
Dyspnea 43 43
Respiratory Insufficiency 40 40
Pain 39 39
Hemorrhage/Bleeding 38 38
Discomfort 37 37
Blood Loss 34 34
Death 34 34
Tachycardia 25 25
Injury 25 25
Cardiac Arrest 21 21
Aspiration/Inhalation 18 18
Irritation 18 18
Inflammation 17 17
Respiratory Failure 17 17
Skin Inflammation/ Irritation 17 17
Hemoptysis 15 15
Unspecified Infection 14 14
Distress 13 13
Pneumothorax 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Foreign Body In Patient 11 11
Unspecified Respiratory Problem 11 11
Bradycardia 10 10
Increased Respiratory Rate 9 9
Obstruction/Occlusion 8 8
Respiratory Tract Infection 8 8
Ventilator Dependent 8 8
Pressure Sores 8 8
Anxiety 8 8
Dysphasia 8 8
Pneumonia 8 8
Granuloma 7 7
Patient Problem/Medical Problem 7 7
Fistula 6 6
Cyanosis 6 6
Asphyxia 5 5
Apnea 5 5
Laceration(s) 5 5
Low Blood Pressure/ Hypotension 5 5
Stenosis 5 5
Ulcer 5 5
Sore Throat 4 4
Irritability 4 4
Forced Expiratory Volume Decreased 4 4
Cardiovascular Insufficiency 4 4
Hyperventilation 4 4
Failure of Implant 4 4
Skin Irritation 4 4
Wound Dehiscence 4 4
Chest Pain 4 4
Bacterial Infection 4 4
Hypersensitivity/Allergic reaction 4 4
Dysphagia/ Odynophagia 4 4
Pulmonary Emphysema 4 4
Erythema 4 4
Swelling/ Edema 4 4
Localized Skin Lesion 3 3
Cardiopulmonary Arrest 3 3
Pleural Effusion 3 3
Cough 3 3
Respiratory Arrest 3 3
Device Embedded In Tissue or Plaque 3 3
Missing Value Reason 3 3
Tissue Breakdown 3 3
Respiratory Acidosis 3 3
Sudden Cardiac Death 3 3
Swelling 3 3
Skin Tears 2 2
Fluid Discharge 2 2
Not Applicable 2 2
Unspecified Heart Problem 2 2
Convulsion/Seizure 2 2
Perforation 2 2
Infiltration into Tissue 2 2
Suffocation 2 2
Ventricular Fibrillation 2 2
Pulmonary Edema 2 2
Rash 2 2
Local Reaction 2 2
Respiratory Distress Syndrome of Newborns 2 2
Exposure to Body Fluids 2 2
Abrasion 2 2
Asthma 2 2
High Blood Pressure/ Hypertension 2 2

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
9 Smiths Medical ASD, Inc. II Feb-09-2018
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