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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 144 144

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 1144 1144
Use of Device Problem 999 999
Inflation Problem 822 822
Defective Component 397 397
Material Split, Cut or Torn 391 391
Leak/Splash 284 284
Break 223 223
Connection Problem 210 210
Disconnection 187 187
Defective Device 112 112
Material Separation 110 110
Appropriate Term/Code Not Available 107 107
Fluid/Blood Leak 103 103
Crack 94 94
Material Puncture/Hole 87 87
Fracture 82 82
Insufficient Information 81 81
Physical Resistance/Sticking 70 70
Human-Device Interface Problem 70 70
Obstruction of Flow 58 58
Device Markings/Labelling Problem 51 51
Deflation Problem 50 50
Inadequacy of Device Shape and/or Size 47 47
Material Fragmentation 45 45
Labelling, Instructions for Use or Training Problem 43 43
Material Rupture 42 42
Patient Device Interaction Problem 41 41
Material Discolored 37 37
Patient-Device Incompatibility 37 37
Contamination 37 37
Detachment of Device or Device Component 35 35
Material Integrity Problem 35 35
Mechanical Problem 35 35
Component Missing 31 31
Material Deformation 30 30
Unintended Deflation 30 30
Difficult to Advance 28 28
Tear, Rip or Hole in Device Packaging 27 27
Product Quality Problem 26 26
No Apparent Adverse Event 24 24
Adverse Event Without Identified Device or Use Problem 23 23
Deformation Due to Compressive Stress 22 22
Difficult to Insert 22 22
Contamination /Decontamination Problem 21 21
Material Twisted/Bent 19 19
Fitting Problem 19 19
Gel Leak 18 18
Device-Device Incompatibility 18 18
Loose or Intermittent Connection 17 17
Microbial Contamination of Device 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2823 2823
Unintended Extubation 1423 1423
Insufficient Information 733 733
No Consequences Or Impact To Patient 450 450
Low Oxygen Saturation 158 158
Extubate 123 123
Hypoventilation 112 112
Decreased Respiratory Rate 82 82
No Patient Involvement 76 76
No Information 68 68
Airway Obstruction 59 59
Unspecified Tissue Injury 56 56
Hemorrhage/Bleeding 52 52
Dyspnea 51 51
Respiratory Insufficiency 48 48
Discomfort 35 35
Tachycardia 25 25
Skin Inflammation/ Irritation 24 24
Pain 24 24
Hypoxia 24 24
Cardiac Arrest 19 19
Death 18 18
No Code Available 17 17
Distress 15 15
Aspiration/Inhalation 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
Foreign Body In Patient 13 13
Pneumonia 12 12
Inflammation 12 12
Injury 11 11
Unspecified Infection 11 11
Bradycardia 10 10
No Known Impact Or Consequence To Patient 10 10
Pneumothorax 10 10
Failure of Implant 9 9
Respiratory Tract Infection 8 8
Dysphasia 8 8
Cough 8 8
Obstruction/Occlusion 7 7
High Oxygen Saturation 7 7
Pressure Sores 7 7
Sore Throat 7 7
Low Blood Pressure/ Hypotension 6 6
Anxiety 6 6
Bacterial Infection 6 6
Stenosis 6 6
Irritation 6 6

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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