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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheostomy (w/wo connector)
Regulation Description Tracheostomy tube and tube cuff.
Product CodeBTO
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
VITALTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 113 113
2021 198 198
2022 770 770
2023 402 402
2024 418 418
2025 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 342 342
Inflation Problem 186 186
Leak/Splash 179 179
Break 143 143
Detachment of Device or Device Component 116 116
Disconnection 89 89
Crack 83 83
Defective Component 58 58
Material Separation 50 50
Material Split, Cut or Torn 49 49
Material Puncture/Hole 48 48
Fluid/Blood Leak 46 46
Contamination /Decontamination Problem 45 45
Connection Problem 45 45
Component Missing 43 43
Unintended Deflation 40 40
Device Markings/Labelling Problem 37 37
Fracture 37 37
Separation Problem 31 31
Defective Device 28 28
Obstruction of Flow 25 25
Deflation Problem 24 24
Incomplete or Missing Packaging 22 22
Use of Device Problem 21 21
Decrease in Pressure 20 20
Material Deformation 20 20
Loose or Intermittent Connection 19 19
Fitting Problem 16 16
Suction Problem 16 16
Device Damaged Prior to Use 16 16
Insufficient Information 16 16
Mechanical Problem 15 15
Tear, Rip or Hole in Device Packaging 15 15
Inadequacy of Device Shape and/or Size 14 14
Pressure Problem 14 14
Material Rupture 13 13
Difficult to Insert 13 13
Moisture or Humidity Problem 11 11
Gel Leak 11 11
Material Discolored 11 11
Material Twisted/Bent 10 10
Patient Device Interaction Problem 10 10
Device Dislodged or Dislocated 9 9
Nonstandard Device 9 9
Material Fragmentation 9 9
Complete Blockage 8 8
Physical Resistance/Sticking 8 8
Material Too Soft/Flexible 8 8
Deformation Due to Compressive Stress 8 8
Misconnection 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1554 1554
Insufficient Information 224 224
No Consequences Or Impact To Patient 74 74
Low Oxygen Saturation 30 30
Decreased Respiratory Rate 29 29
Airway Obstruction 15 15
Extubate 13 13
No Information 11 11
Dyspnea 9 9
Unintended Extubation 8 8
Respiratory Insufficiency 8 8
Hypoxia 7 7
Hypoventilation 6 6
Bradycardia 6 6
Aspiration Pneumonitis 6 6
Hemorrhage/Bleeding 6 6
No Patient Involvement 5 5
Cardiac Arrest 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Aspiration/Inhalation 4 4
Fever 3 3
Abrasion 3 3
Fistula 3 3
Blister 2 2
Ventilator Dependent 2 2
Skin Inflammation/ Irritation 2 2
Brain Injury 2 2
Failure of Implant 2 2
Foreign Body In Patient 2 2
Chest Pain 2 2
Device Embedded In Tissue or Plaque 2 2
Swelling/ Edema 2 2
Pneumonia 2 2
Pneumothorax 2 2
Sore Throat 1 1
Infiltration into Tissue 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1
Unspecified Respiratory Problem 1 1
Stomatitis 1 1
Salivary Hypersecretion 1 1
Bronchospasm 1 1
Forced Expiratory Volume Decreased 1 1
Chemosis 1 1
Bruise/Contusion 1 1
Hematemesis 1 1
Choking 1 1
Pain 1 1
Respiratory Tract Infection 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 Smiths Medical ASD Inc. I Sep-11-2024
3 Smiths Medical ASD Inc. I Aug-23-2024
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