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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
  1.  K192511  Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, ...

MDR Year MDR Reports MDR Events
2017 125 125
2018 162 162
2019 87 87
2020 112 112
2021 192 192
2022 768 768

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 205 205
Inflation Problem 134 134
Gas/Air Leak 119 119
Break 91 91
Detachment of Device or Device Component 80 80
Air Leak 52 52
Connection Problem 49 49
Disconnection 43 43
Defective Component 40 40
Crack 37 37
Fluid/Blood Leak 34 34
Component Missing 33 33
Material Split, Cut or Torn 32 32
Separation Problem 24 24
Contamination /Decontamination Problem 24 24
Material Integrity Problem 23 23
Defective Device 21 21
Device Damaged Prior to Use 21 21
Use of Device Problem 21 21
Material Puncture/Hole 20 20
Accessory Incompatible 20 20
Device Markings/Labelling Problem 20 20
Decrease in Pressure 19 19
Human-Device Interface Problem 18 18
Material Deformation 18 18
Material Separation 17 17
Obstruction of Flow 16 16
Deflation Problem 15 15
Inadequacy of Device Shape and/or Size 14 14
Tear, Rip or Hole in Device Packaging 14 14
Material Discolored 13 13
Incomplete or Missing 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
Mechanical Problem 10 10
Moisture or Humidity Problem 10 10
Pressure Problem 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Insufficient Information 9 9
Nonstandard Device 9 9
Patient Device Interaction Problem 8 8
Device Dislodged or Dislocated 8 8
Material Twisted/Bent 7 7
Material Rupture 7 7
Difficult to Insert 7 7
Noise, Audible 7 7
Material Fragmentation 6 6
Material Perforation 6 6
Physical Resistance/Sticking 6 6
Torn Material 6 6
Device Operates Differently Than Expected 6 6
Deformation Due to Compressive Stress 5 5
Positioning Problem 5 5
Problem with Sterilization 5 5
Labelling, Instructions for Use or Training Problem 5 5
Degraded 5 5
Device Alarm System 5 5
Complete Blockage 5 5
Unintended Deflation 5 5
Premature Separation 5 5
Detachment Of Device Component 4 4
Sticking 4 4
Unsealed Device Packaging 4 4
Material Too Soft/Flexible 4 4
Packaging Problem 4 4
Optical Discoloration 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
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
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Mechanical Jam 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Unintended Movement 2 2
Misassembly by Users 1 1
Device Difficult to Maintain 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 825 825
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 19 19
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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