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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
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRACOE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K203362  TRACOE vario

MDR Year MDR Reports MDR Events
2019 1019 1019
2020 791 791
2021 1041 1041
2022 1633 1633
2023 1233 1233
2024 1103 1103
2025 144 144

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 1209 1209
Use of Device Problem 1078 1078
Inflation Problem 938 938
Leak/Splash 514 514
Material Split, Cut or Torn 433 433
Defective Component 420 420
Break 267 267
Disconnection 228 228
Connection Problem 222 222
Crack 153 153
Material Separation 134 134
Defective Device 126 126
Fluid/Blood Leak 122 122
Material Puncture/Hole 116 116
Appropriate Term/Code Not Available 113 113
Fracture 106 106
Insufficient Information 92 92
Detachment of Device or Device Component 91 91
Physical Resistance/Sticking 84 84
Human-Device Interface Problem 83 83
Inadequacy of Device Shape and/or Size 80 80
Material Discolored 73 73
Obstruction of Flow 67 67
Material Integrity Problem 61 61
Deflation Problem 61 61
Material Rupture 56 56
Device Markings/Labelling Problem 55 55
Material Fragmentation 51 51
Mechanical Problem 49 49
Labelling, Instructions for Use or Training Problem 47 47
Patient Device Interaction Problem 43 43
Patient-Device Incompatibility 43 43
Contamination 39 39
Component Missing 36 36
Material Deformation 32 32
Adverse Event Without Identified Device or Use Problem 32 32
Unintended Deflation 30 30
Product Quality Problem 29 29
Difficult to Advance 28 28
Tear, Rip or Hole in Device Packaging 27 27
Contamination /Decontamination Problem 27 27
Deformation Due to Compressive Stress 24 24
No Apparent Adverse Event 24 24
Difficult to Insert 23 23
Separation Problem 22 22
Material Twisted/Bent 20 20
Gel Leak 20 20
Fitting Problem 20 20
Loose or Intermittent Connection 19 19
Difficult to Remove 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2828 2828
Unintended Extubation 1423 1423
No Consequences Or Impact To Patient 815 815
Insufficient Information 733 733
Extubate 264 264
No Information 217 217
No Known Impact Or Consequence To Patient 207 207
Low Oxygen Saturation 180 180
No Patient Involvement 147 147
Hypoventilation 114 114
Decreased Respiratory Rate 82 82
Airway Obstruction 64 64
Dyspnea 61 61
Unspecified Tissue Injury 57 57
Hemorrhage/Bleeding 54 54
No Code Available 54 54
Respiratory Insufficiency 48 48
Discomfort 41 41
Respiratory Distress 39 39
Hypoxia 36 36
Pain 33 33
Death 31 31
Tachycardia 26 26
Skin Inflammation/ Irritation 24 24
Inflammation 21 21
Cardiac Arrest 19 19
Distress 16 16
Aspiration/Inhalation 16 16
Irritation 16 16
Respiratory Failure 15 15
Pneumonia 14 14
Unspecified Infection 14 14
Injury 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Unspecified Respiratory Problem 13 13
Foreign Body In Patient 13 13
Pneumothorax 12 12
Bradycardia 10 10
Failure of Implant 9 9
Pressure Sores 8 8
Cough 8 8
Respiratory Tract Infection 8 8
Dysphasia 8 8
Increased Respiratory Rate 7 7
High Oxygen Saturation 7 7
Obstruction/Occlusion 7 7
Stenosis 7 7
Anxiety 7 7
Low Blood Pressure/ Hypotension 7 7
Sore Throat 7 7

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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