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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
  1.  K193133  Blue Rhino G1-Multi Percutaneous Tracheostomy Intr ...
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 546 546

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 1029 1029
Use of Device Problem 941 941
Inflation Problem 871 871
Leak/Splash 509 509
Defective Component 398 398
Material Split, Cut or Torn 353 353
Break 242 242
Connection Problem 220 220
Disconnection 160 160
Crack 138 138
Defective Device 125 125
Material Separation 117 117
Fluid/Blood Leak 116 116
Material Puncture/Hole 112 112
Fracture 96 96
Appropriate Term/Code Not Available 96 96
Insufficient Information 89 89
Detachment of Device or Device Component 88 88
Inadequacy of Device Shape and/or Size 80 80
Human-Device Interface Problem 77 77
Physical Resistance/Sticking 77 77
Material Discolored 71 71
Obstruction of Flow 66 66
Material Integrity Problem 59 59
Deflation Problem 56 56
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
Contamination 36 36
Component Missing 35 35
Material Deformation 31 31
Adverse Event Without Identified Device or Use Problem 30 30
Product Quality Problem 29 29
Difficult to Advance 27 27
Unintended Deflation 27 27
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
Separation Problem 20 20
Gel Leak 20 20
Difficult to Remove 19 19
Material Twisted/Bent 19 19
Loose or Intermittent Connection 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
Suction Problem 13 13
Fungus in Device Environment 13 13
Device Contaminated During Manufacture or Shipping 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Device Contaminated at the User Facility 12 12
Failure to Deflate 11 11
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
Device Damaged Prior to Use 9 9
Separation Failure 9 9
Installation-Related Problem 9 9
Burst Container or Vessel 9 9
Failure to Seal 9 9
Filling Problem 8 8
Material Too Rigid or Stiff 8 8
Scratched Material 8 8
Malposition of Device 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
Unexpected Color 6 6
Fail-Safe Did Not Operate 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 2403 2403
Unintended Extubation 1202 1202
No Consequences Or Impact To Patient 815 815
Insufficient Information 674 674
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 97 97
Decreased Respiratory Rate 78 78
Airway Obstruction 63 63
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
Discomfort 30 30
Pain 29 29
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
Stenosis 7 7
Anxiety 7 7
Increased Respiratory Rate 7 7
High Oxygen Saturation 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
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

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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