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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 112 112
2021 192 192
2022 706 706

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 204 204
Inflation Problem 131 131
Gas/Air Leak 98 98
Break 90 90
Detachment of Device or Device Component 74 74
Air Leak 52 52
Connection Problem 45 45
Disconnection 42 42
Defective Component 39 39
Fluid/Blood Leak 34 34
Crack 34 34
Component Missing 32 32
Material Split, Cut or Torn 30 30
Separation Problem 24 24
Contamination /Decontamination Problem 24 24
Material Integrity Problem 23 23
Device Damaged Prior to Use 21 21
Use of Device Problem 21 21
Material Puncture/Hole 20 20
Accessory Incompatible 20 20
Defective Device 20 20
Decrease in Pressure 19 19
Human-Device Interface Problem 18 18
Device Markings/Labelling Problem 18 18
Material Deformation 18 18
Material Separation 17 17
Obstruction of Flow 15 15
Inadequacy of Device Shape and/or Size 14 14
Deflation Problem 14 14
Material Discolored 13 13
Incomplete or Missing Packaging 12 12
Tear, Rip or Hole in Device Packaging 12 12
Suction Problem 11 11
Fracture 11 11
Gel Leak 11 11
Difficult to Remove 10 10
Loose or Intermittent Connection 10 10
Pressure Problem 10 10
Insufficient Information 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Mechanical Problem 9 9
Device Dislodged or Dislocated 8 8
Patient Device Interaction Problem 8 8
Noise, Audible 7 7
Material Twisted/Bent 7 7
Material Rupture 7 7
Difficult to Insert 7 7
Material Fragmentation 6 6
Material Perforation 6 6
Torn Material 6 6
Physical Resistance/Sticking 6 6
Device Operates Differently Than Expected 6 6
Deformation Due to Compressive Stress 5 5
Premature Separation 5 5
Positioning Problem 5 5
Problem with Sterilization 5 5
Degraded 5 5
Device Alarm System 5 5
Complete Blockage 5 5
Detachment Of Device Component 4 4
Labelling, Instructions for Use or Training Problem 4 4
Sticking 4 4
Unsealed Device Packaging 4 4
Packaging Problem 4 4
Optical Discoloration 4 4
Material Too Soft/Flexible 4 4
Contamination of Device Ingredient or Reagent 4 4
Infusion or Flow Problem 3 3
Malposition of Device 3 3
Patient-Device Incompatibility 3 3
Expiration Date Error 3 3
Product Quality Problem 3 3
Misassembled 3 3
Partial Blockage 3 3
Inaccurate Information 3 3
Unintended Deflation 3 3
Unexpected Color 2 2
Failure to Deflate 2 2
Unable to Obtain Readings 2 2
Migration or Expulsion of Device 2 2
Device Difficult to Setup or Prepare 2 2
Insufficient Flow or Under Infusion 2 2
Fitting Problem 2 2
Dull, Blunt 2 2
Cut In Material 2 2
Blocked Connection 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Compatibility Problem 2 2
Difficult to Advance 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Mechanical Jam 2 2
Unintended Movement 2 2
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Physical Property Issue 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 764 764
No Consequences Or Impact To Patient 270 270
Insufficient Information 79 79
No Known Impact Or Consequence To Patient 66 66
No Information 38 39
Extubate 32 32
Low Oxygen Saturation 18 18
No Patient Involvement 14 14
Decreased Respiratory Rate 13 13
No Code Available 12 12
Airway Obstruction 12 12
Hemorrhage/Bleeding 10 10
Dyspnea 9 9
Death 7 7
Discomfort 7 7
Foreign Body In Patient 6 6
Unintended Extubation 6 6
Hypoxia 6 6
Aspiration/Inhalation 5 5
Cardiac Arrest 4 4
Hypoventilation 4 4
Pneumothorax 4 4
Respiratory Distress 3 3
Tissue Damage 3 3
Abrasion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pneumonia 3 3
Patient Problem/Medical Problem 3 3
Blood Loss 3 3
Swelling/ Edema 2 2
Brain Injury 2 2
Ulcer 2 2
Pressure Sores 2 2
Respiratory Failure 2 2
Bradycardia 2 2
Apnea 2 2
Fever 2 2
Fistula 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
Perforation 1 1
Pulmonary Edema 1 1
Thrombosis 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
Loss Of Pulse 1 1
Obstruction/Occlusion 1 1
Skin Inflammation 1 1
Needle Stick/Puncture 1 1
Nasal Obstruction 1 1
Distress 1 1
Injury 1 1
Ventilator Dependent 1 1
Laceration(s) of Esophagus 1 1
Device Embedded In Tissue or Plaque 1 1
Diminished Pulse Pressure 1 1
Cardiovascular Insufficiency 1 1
Respiratory Insufficiency 1 1
Hematemesis 1 1
Urethral Stenosis/Stricture 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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