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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
2018 162 162
2019 87 87
2020 112 112
2021 199 199
2022 771 771
2023 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 187 187
Inflation Problem 144 144
Gas/Air Leak 142 142
Break 96 96
Detachment of Device or Device Component 93 93
Connection Problem 52 52
Crack 47 47
Disconnection 46 46
Defective Component 45 45
Component Missing 38 38
Fluid/Blood Leak 38 38
Material Split, Cut or Torn 36 36
Separation Problem 27 27
Contamination /Decontamination Problem 24 24
Device Markings/Labelling Problem 23 23
Defective Device 23 23
Use of Device Problem 23 23
Material Puncture/Hole 23 23
Device Damaged Prior to Use 21 21
Obstruction of Flow 21 21
Material Integrity Problem 20 20
Accessory Incompatible 20 20
Air Leak 19 19
Human-Device Interface Problem 19 19
Material Deformation 19 19
Deflation Problem 18 18
Incomplete or Missing Packaging 18 18
Material Separation 17 17
Tear, Rip or Hole in Device Packaging 14 14
Inadequacy of Device Shape and/or Size 14 14
Fracture 14 14
Material Discolored 14 14
Decrease in Pressure 13 13
Suction Problem 13 13
Gel Leak 11 11
Mechanical Problem 11 11
Insufficient Information 11 11
Unintended Deflation 11 11
Moisture or Humidity Problem 10 10
Pressure Problem 10 10
Patient Device Interaction Problem 9 9
Loose or Intermittent Connection 9 9
Nonstandard Device 9 9
Difficult to Remove 8 8
Difficult to Insert 8 8
Material Twisted/Bent 8 8
Noise, Audible 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Device Dislodged or Dislocated 7 7
Expiration Date Error 6 6
Deformation Due to Compressive Stress 6 6
Material Too Soft/Flexible 6 6
Physical Resistance/Sticking 6 6
Material Fragmentation 6 6
Material Rupture 6 6
Problem with Sterilization 5 5
Labelling, Instructions for Use or Training Problem 5 5
Degraded 5 5
Complete Blockage 5 5
Premature Separation 5 5
Packaging Problem 5 5
Positioning Problem 5 5
Optical Discoloration 4 4
Contamination of Device Ingredient or Reagent 4 4
Unsealed Device Packaging 4 4
Product Quality Problem 3 3
Sticking 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Deliver 3 3
Partial Blockage 3 3
Patient-Device Incompatibility 3 3
Separation Failure 3 3
Infusion or Flow Problem 3 3
Inaccurate Information 3 3
Unexpected Color 2 2
Failure to Deflate 2 2
Difficult to Advance 2 2
Device Operates Differently Than Expected 2 2
Failure to Disconnect 2 2
Malposition of Device 2 2
Blocked Connection 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Mechanical Jam 2 2
Torn Material 2 2
Appropriate Term/Code Not Available 2 2
Misassembled 2 2
Moisture Damage 2 2
Dull, Blunt 2 2
Insufficient Flow or Under Infusion 2 2
Material Perforation 2 2
Device Difficult to Setup or Prepare 2 2
Material Too Rigid or Stiff 2 2
Unable to Obtain Readings 2 2
Pumping Stopped 1 1
Particulates 1 1
Occlusion Within Device 1 1
Stretched 1 1
Tidal Volume Fluctuations 1 1
Failure to Unfold or Unwrap 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 943 943
No Consequences Or Impact To Patient 198 198
Insufficient Information 114 114
No Known Impact Or Consequence To Patient 43 43
No Information 33 34
Extubate 30 30
Decreased Respiratory Rate 29 29
Low Oxygen Saturation 18 18
Airway Obstruction 17 17
No Patient Involvement 14 14
No Code Available 11 11
Dyspnea 10 10
Hemorrhage/Bleeding 8 8
Unintended Extubation 8 8
Hypoxia 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body In Patient 4 4
Death 4 4
Tissue Damage 3 3
Abrasion 3 3
Respiratory Distress 3 3
Hypoventilation 3 3
Patient Problem/Medical Problem 3 3
Respiratory Insufficiency 3 3
Cardiac Arrest 3 3
Pneumonia 3 3
Pneumothorax 2 2
Fistula 2 2
Laceration(s) of Esophagus 2 2
Device Embedded In Tissue or Plaque 2 2
Pain 2 2
Blister 2 2
Fever 2 2
Swelling/ Edema 2 2
Respiratory Failure 2 2
Failure of Implant 2 2
Aspiration/Inhalation 2 2
Brain Injury 2 2
Confusion/ Disorientation 1 1
Diminished Pulse Pressure 1 1
Bradycardia 1 1
Hematemesis 1 1
Swelling 1 1
Thrombosis 1 1
Ventricular Tachycardia 1 1
Infiltration into Tissue 1 1
Hypovolemic Shock 1 1
Ulcer 1 1
Ventilator Dependent 1 1
Myocardial Hypertrophy 1 1
Chemosis 1 1
Skin Inflammation 1 1
Diaphoresis 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Apnea 1 1
Cardiovascular Insufficiency 1 1
Pulmonary Edema 1 1
Obstruction/Occlusion 1 1
Perforation 1 1
Urethral Stenosis/Stricture 1 1
Needle Stick/Puncture 1 1
Loss Of Pulse 1 1
Blood Loss 1 1
Granuloma 1 1
Unspecified Infection 1 1
Chest Pain 1 1
Ventricular Fibrillation 1 1
Discomfort 1 1
Injury 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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