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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)
Product CodeBTO
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITHS MEDICAL ADS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 125 125
2018 162 162
2019 87 87
2020 111 111
2021 192 192
2022 252 252

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 134 134
Gas Leak 83 83
Inflation Problem 79 79
Break 56 56
Air Leak 52 52
Detachment of Device or Device Component 39 39
Disconnection 34 34
Connection Problem 28 28
Material Integrity Problem 21 21
Separation Problem 20 20
Accessory Incompatible 20 20
Fluid Leak 20 20
Defective Component 20 20
Crack 19 19
Decrease in Pressure 18 18
Use of Device Problem 18 18
Human-Device Interface Problem 18 18
Material Split, Cut or Torn 17 17
Inadequacy of Device Shape and/or Size 13 13
Obstruction of Flow 13 13
Deflation Problem 13 13
Material Puncture/Hole 12 12
Gel Leak 11 11
Defective Device 11 11
Contamination /Decontamination Problem 10 10
Pressure Problem 10 10
Difficult to Remove 10 10
Component Missing 10 10
Material Discolored 10 10
Fracture 9 9
Loose or Intermittent Connection 9 9
Insufficient Information 8 8
Device Damaged Prior to Use 8 8
Device Dislodged or Dislocated 8 8
Noise, Audible 7 7
Mechanical Problem 7 7
Material Rupture 7 7
Material Separation 6 6
Suction Problem 6 6
Torn Material 6 6
Device Operates Differently Than Expected 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Material Deformation 5 5
Positioning Problem 5 5
Problem with Sterilization 5 5
Material Perforation 5 5
Degraded 5 5
Device Alarm System 5 5
Detachment Of Device Component 4 4
Material Fragmentation 4 4
Difficult to Insert 4 4
Tear, Rip or Hole in Device Packaging 4 4
Sticking 4 4
Physical Resistance/Sticking 4 4
Material Too Soft/Flexible 4 4
Contamination of Device Ingredient or Reagent 4 4
Device Markings/Labelling Problem 4 4
Malposition of Device 3 3
Patient-Device Incompatibility 3 3
Infusion or Flow Problem 3 3
Material Twisted/Bent 3 3
Inaccurate Information 3 3
Patient Device Interaction Problem 3 3
Expiration Date Error 3 3
Labelling, Instructions for Use or Training Problem 3 3
Misassembled 3 3
Partial Blockage 3 3
Complete Blockage 3 3
Migration or Expulsion of Device 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Cut In Material 2 2
Dull, Blunt 2 2
Insufficient Flow or Under Infusion 2 2
Fitting Problem 2 2
Unable to Obtain Readings 2 2
Unsealed Device Packaging 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Premature Separation 2 2
Unintended Deflation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Compatibility Problem 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Difficult to Advance 2 2
Difficult to Open or Close 1 1
Device-Device Incompatibility 1 1
Activation, Positioning or SeparationProblem 1 1
Ambient Noise Problem 1 1
Human Factors Issue 1 1
Optical Obstruction 1 1
Output Problem 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Material Protrusion/Extrusion 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 325 325
No Consequences Or Impact To Patient 270 270
Insufficient Information 75 75
No Known Impact Or Consequence To Patient 66 66
No Information 38 39
Extubate 32 32
Low Oxygen Saturation 17 17
No Patient Involvement 13 13
No Code Available 12 12
Airway Obstruction 11 11
Hemorrhage/Bleeding 10 10
Dyspnea 9 9
Death 7 7
Decreased Respiratory Rate 7 7
Discomfort 7 7
Hypoxia 6 6
Aspiration/Inhalation 5 5
Foreign Body In Patient 5 5
Unintended Extubation 4 4
Hypoventilation 4 4
Pneumothorax 4 4
Pneumonia 3 3
Respiratory Distress 3 3
Tissue Damage 3 3
Abrasion 3 3
Cardiac Arrest 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Patient Problem/Medical Problem 3 3
Blood Loss 3 3
Brain Injury 2 2
Ulcer 2 2
Pressure Sores 2 2
Bradycardia 2 2
Apnea 2 2
Fever 2 2
Ventricular Fibrillation 2 2
Ventricular Tachycardia 2 2
Swelling 2 2
Pain 2 2
Irritation 2 2
Failure of Implant 2 2
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Hypovolemic Shock 1 1
Pulmonary Edema 1 1
Thrombosis 1 1
Fistula 1 1
Granuloma 1 1
Pulmonary Emphysema 1 1
Encephalopathy 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Chemosis 1 1
Chest Pain 1 1
Distress 1 1
Injury 1 1
Ventilator Dependent 1 1
Laceration(s) of Esophagus 1 1
Loss Of Pulse 1 1
Respiratory Failure 1 1
Obstruction/Occlusion 1 1
Skin Inflammation 1 1
Nasal Obstruction 1 1
Diminished Pulse Pressure 1 1
Cardiovascular Insufficiency 1 1
Respiratory Insufficiency 1 1
Hematemesis 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Jun-04-2019
2 Smiths Medical ASD Inc. II Jun-07-2018
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