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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
Regulation Description Tracheostomy tube and tube cuff.
Product CodeJOH
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRACOE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 791 791
2021 1041 1041
2022 1633 1633
2023 1233 1233
2024 1103 1103
2025 551 551

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 1223 1223
Use of Device Problem 1119 1119
Inflation Problem 876 876
Material Split, Cut or Torn 433 433
Defective Component 415 415
Leak/Splash 286 286
Break 249 249
Disconnection 229 229
Connection Problem 212 212
Material Separation 117 117
Defective Device 112 112
Appropriate Term/Code Not Available 110 110
Fluid/Blood Leak 109 109
Crack 106 106
Insufficient Information 90 90
Material Puncture/Hole 88 88
Fracture 85 85
Physical Resistance/Sticking 78 78
Human-Device Interface Problem 72 72
Obstruction of Flow 60 60
Deflation Problem 58 58
Device Markings/Labelling Problem 54 54
Inadequacy of Device Shape and/or Size 48 48
Material Fragmentation 45 45
Labelling, Instructions for Use or Training Problem 44 44
Material Rupture 43 43
Patient Device Interaction Problem 42 42
Contamination 41 41
Patient-Device Incompatibility 41 41
Material Discolored 40 40
Mechanical Problem 38 38
Material Integrity Problem 38 38
Detachment of Device or Device Component 35 35
Component Missing 35 35
Unintended Deflation 32 32
Material Deformation 31 31
No Apparent Adverse Event 30 30
Difficult to Advance 30 30
Tear, Rip or Hole in Device Packaging 28 28
Product Quality Problem 27 27
Adverse Event Without Identified Device or Use Problem 23 23
Difficult to Insert 23 23
Contamination /Decontamination Problem 22 22
Deformation Due to Compressive Stress 22 22
Material Twisted/Bent 20 20
Device-Device Incompatibility 20 20
Fitting Problem 19 19
Gel Leak 18 18
Loose or Intermittent Connection 18 18
Microbial Contamination of Device 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3127 3127
Unintended Extubation 1525 1525
Insufficient Information 752 752
No Consequences Or Impact To Patient 450 450
Low Oxygen Saturation 160 160
Extubate 123 123
Hypoventilation 113 113
Decreased Respiratory Rate 82 82
No Patient Involvement 76 76
No Information 68 68
Airway Obstruction 59 59
Unspecified Tissue Injury 58 58
Hemorrhage/Bleeding 57 57
Dyspnea 54 54
Respiratory Insufficiency 50 50
Discomfort 35 35
Tachycardia 25 25
Hypoxia 25 25
Pain 24 24
Skin Inflammation/ Irritation 24 24
Cardiac Arrest 20 20
Distress 19 19
Death 18 18
No Code Available 17 17
Aspiration/Inhalation 17 17
Foreign Body In Patient 15 15
Respiratory Distress 14 14
Respiratory Failure 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Unspecified Respiratory Problem 13 13
Inflammation 13 13
Pneumonia 12 12
Cough 11 11
Injury 11 11
Unspecified Infection 11 11
Pneumothorax 11 11
No Known Impact Or Consequence To Patient 10 10
Bradycardia 10 10
Failure of Implant 9 9
Dysphasia 8 8
Respiratory Tract Infection 8 8
Pressure Sores 7 7
Sore Throat 7 7
Obstruction/Occlusion 7 7
High Oxygen Saturation 7 7
Stenosis 6 6
Anxiety 6 6
Ventilator Dependent 6 6
Irritation 6 6
Increased Respiratory Rate 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Cook Incorporated I May-10-2023
2 Covidien I Mar-25-2025
3 Covidien I Apr-19-2023
4 Smiths Medical ASD Inc. II Oct-31-2023
5 Smiths Medical ASD Inc. II Jul-01-2021
6 Smiths Medical ASD Inc. II Feb-23-2021
7 Smiths Medical ASD Inc. II Dec-28-2020
8 Smiths Medical ASD Inc. II Sep-09-2020
9 Smiths Medical ASD Inc. II Jul-01-2020
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