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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
TELEFLEX MEDICAL
  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 113 113
2021 198 198
2022 770 770
2023 402 402
2024 119 119

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 240 240
Leak/Splash 223 223
Inflation Problem 198 198
Break 133 133
Detachment of Device or Device Component 113 113
Crack 59 59
Defective Component 58 58
Disconnection 56 56
Connection Problem 55 55
Air Leak 52 52
Contamination /Decontamination Problem 47 47
Component Missing 47 47
Material Separation 46 46
Material Split, Cut or Torn 42 42
Material Puncture/Hole 40 40
Fluid/Blood Leak 40 40
Fracture 33 33
Device Markings/Labelling Problem 33 33
Separation Problem 31 31
Defective Device 28 28
Obstruction of Flow 25 25
Decrease in Pressure 25 25
Unintended Deflation 25 25
Material Integrity Problem 24 24
Material Deformation 23 23
Use of Device Problem 23 23
Deflation Problem 23 23
Incomplete or Missing Packaging 22 22
Device Damaged Prior to Use 22 22
Human-Device Interface Problem 20 20
Accessory Incompatible 20 20
Inadequacy of Device Shape and/or Size 19 19
Loose or Intermittent Connection 16 16
Tear, Rip or Hole in Device Packaging 16 16
Insufficient Information 16 16
Mechanical Problem 15 15
Material Discolored 15 15
Suction Problem 14 14
Pressure Problem 12 12
Material Rupture 12 12
Gel Leak 11 11
Difficult to Insert 10 10
Difficult to Remove 10 10
Material Twisted/Bent 10 10
Moisture or Humidity Problem 10 10
Patient Device Interaction Problem 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Nonstandard Device 9 9
Material Fragmentation 9 9
Device Dislodged or Dislocated 8 8
Deformation Due to Compressive Stress 7 7
Degraded 7 7
Material Too Soft/Flexible 7 7
Physical Resistance/Sticking 7 7
Noise, Audible 7 7
Complete Blockage 6 6
Device Operates Differently Than Expected 6 6
Material Perforation 6 6
Expiration Date Error 6 6
Torn Material 6 6
Positioning Problem 5 5
Packaging Problem 5 5
Device Alarm System 5 5
Labelling, Instructions for Use or Training Problem 5 5
Problem with Sterilization 5 5
Premature Separation 5 5
Sticking 4 4
Unsealed Device Packaging 4 4
Product Quality Problem 4 4
Partial Blockage 4 4
Detachment Of Device Component 4 4
No Pressure 4 4
Optical Discoloration 4 4
Insufficient Flow or Under Infusion 4 4
Contamination of Device Ingredient or Reagent 4 4
Separation Failure 4 4
Malposition of Device 3 3
Patient-Device Incompatibility 3 3
Fitting Problem 3 3
Device Contamination with Body Fluid 3 3
Failure to Deliver 3 3
Infusion or Flow Problem 3 3
Component Incompatible 3 3
Misassembled 3 3
Improper or Incorrect Procedure or Method 3 3
Tidal Volume Fluctuations 3 3
Inaccurate Information 3 3
Sharp Edges 3 3
Appropriate Term/Code Not Available 2 2
Incomplete or Inadequate Connection 2 2
Unexpected Color 2 2
Failure to Deflate 2 2
Material Too Rigid or Stiff 2 2
Device Difficult to Setup or Prepare 2 2
Shipping Damage or Problem 2 2
Migration or Expulsion of Device 2 2
Moisture Damage 2 2
Unable to Obtain Readings 2 2
Mechanical Jam 2 2
Compatibility Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1194 1194
No Consequences Or Impact To Patient 270 270
Insufficient Information 209 209
No Known Impact Or Consequence To Patient 66 66
No Information 38 39
Extubate 32 32
Low Oxygen Saturation 30 30
Decreased Respiratory Rate 29 29
Airway Obstruction 19 19
No Patient Involvement 15 15
Dyspnea 14 14
No Code Available 12 12
Hemorrhage/Bleeding 10 10
Unintended Extubation 8 8
Death 7 7
Respiratory Insufficiency 7 7
Foreign Body In Patient 7 7
Discomfort 7 7
Aspiration/Inhalation 6 6
Bradycardia 6 6
Hypoventilation 6 6
Hypoxia 6 6
Aspiration Pneumonitis 6 6
Pneumothorax 5 5
Cardiac Arrest 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Abrasion 3 3
Pneumonia 3 3
Pain 3 3
Fistula 3 3
Respiratory Distress 3 3
Tissue Damage 3 3
Patient Problem/Medical Problem 3 3
Blood Loss 3 3
Respiratory Failure 2 2
Device Embedded In Tissue or Plaque 2 2
Ventricular Fibrillation 2 2
Ventricular Tachycardia 2 2
Swelling 2 2
Brain Injury 2 2
Ulcer 2 2
Pressure Sores 2 2
Ventilator Dependent 2 2
Failure of Implant 2 2
Irritation 2 2
Fever 2 2
Apnea 2 2
Swelling/ Edema 2 2
Blister 2 2
Laceration(s) of Esophagus 2 2
Skin Inflammation/ Irritation 1 1
Respiratory Arrest 1 1
Adult Respiratory Distress Syndrome 1 1
Chemosis 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Wound Dehiscence 1 1
Pulmonary Emphysema 1 1
Encephalopathy 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Pulmonary Edema 1 1
Laceration(s) 1 1
Perforation 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Granuloma 1 1
Hypovolemic Shock 1 1
Sore Throat 1 1
Injury 1 1
Obstruction/Occlusion 1 1
Forced Expiratory Volume Decreased 1 1
Skin Inflammation 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Nasal Obstruction 1 1
Distress 1 1
Thrombosis 1 1
Myocardial Hypertrophy 1 1
Hematemesis 1 1
Salivary Hypersecretion 1 1
Stomatitis 1 1
Urethral Stenosis/Stricture 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Diminished Pulse Pressure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 Smiths Medical ASD Inc. II Jun-04-2019
3 Smiths Medical ASD Inc. II Jun-07-2018
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