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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
  1.  K173384  BLUselect, non-fenestrated, BLUselect, non-fenestr ...
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 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
Device Damaged Prior to Use 21 21
Defective Device 21 21
Use of Device Problem 21 21
Material Puncture/Hole 20 20
Device Markings/Labelling Problem 20 20
Accessory Incompatible 20 20
Decrease in Pressure 19 19
Material Deformation 18 18
Human-Device Interface Problem 18 18
Material Separation 17 17
Obstruction of Flow 16 16
Deflation Problem 15 15
Tear, Rip or Hole in Device Packaging 14 14
Inadequacy of Device Shape and/or Size 14 14
Material Discolored 13 13
Incomplete or Missing Packaging 12 12
Fracture 11 11
Gel Leak 11 11
Suction Problem 11 11
Mechanical Problem 10 10
Moisture or Humidity Problem 10 10
Loose or Intermittent Connection 10 10
Difficult to Remove 10 10
Pressure Problem 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Nonstandard Device 9 9
Insufficient Information 9 9
Device Dislodged or Dislocated 8 8
Patient Device Interaction Problem 8 8
Material Twisted/Bent 7 7
Noise, Audible 7 7
Material Rupture 7 7
Difficult to Insert 7 7
Torn Material 6 6
Material Perforation 6 6
Device Operates Differently Than Expected 6 6
Material Fragmentation 6 6
Physical Resistance/Sticking 6 6
Complete Blockage 5 5
Problem with Sterilization 5 5
Labelling, Instructions for Use or Training Problem 5 5
Degraded 5 5
Deformation Due to Compressive Stress 5 5
Unintended Deflation 5 5
Device Alarm System 5 5
Positioning Problem 5 5
Premature Separation 5 5
Packaging Problem 4 4
Material Too Soft/Flexible 4 4
Optical Discoloration 4 4
Unsealed Device Packaging 4 4
Contamination of Device Ingredient or Reagent 4 4
Sticking 4 4
Detachment Of Device Component 4 4
Partial Blockage 3 3
Product Quality Problem 3 3
Patient-Device Incompatibility 3 3
Infusion or Flow Problem 3 3
Inaccurate Information 3 3
Expiration Date Error 3 3
Malposition of Device 3 3
Misassembled 3 3
Unable to Obtain Readings 2 2
Insufficient Flow or Under Infusion 2 2
Dull, Blunt 2 2
Failure to Disconnect 2 2
Difficult to Advance 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Failure to Deflate 2 2
Device Difficult to Setup or Prepare 2 2
Cut In Material 2 2
Blocked Connection 2 2
Separation Failure 2 2
Migration or Expulsion of Device 2 2
Mechanical Jam 2 2
Fitting Problem 2 2
Compatibility Problem 2 2
Unintended Movement 2 2
No Pressure 2 2
Unexpected Color 2 2
Device Fell 1 1
Incomplete or Inadequate Connection 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
Airway Obstruction 12 12
No Code Available 12 12
Hemorrhage/Bleeding 10 10
Dyspnea 9 9
Death 7 7
Discomfort 7 7
Unintended Extubation 6 6
Foreign Body In Patient 6 6
Hypoxia 6 6
Aspiration/Inhalation 5 5
Hypoventilation 4 4
Pneumothorax 4 4
Cardiac Arrest 4 4
Pneumonia 3 3
Respiratory Distress 3 3
Blood Loss 3 3
Abrasion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Tissue Damage 3 3
Patient Problem/Medical Problem 3 3
Swelling/ Edema 2 2
Brain Injury 2 2
Apnea 2 2
Bradycardia 2 2
Ventricular Tachycardia 2 2
Respiratory Failure 2 2
Irritation 2 2
Swelling 2 2
Ventricular Fibrillation 2 2
Pain 2 2
Fistula 2 2
Fever 2 2
Ulcer 2 2
Pressure Sores 2 2
Failure of Implant 2 2
Infiltration into Tissue 1 1
Perforation 1 1
Hypovolemic Shock 1 1
Encephalopathy 1 1
Granuloma 1 1
Hyperventilation 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Chest Pain 1 1
Distress 1 1
Injury 1 1
Ventilator Dependent 1 1
Laceration(s) of Esophagus 1 1
Needle Stick/Puncture 1 1
Loss Of Pulse 1 1
Device Embedded In Tissue or Plaque 1 1
Urethral Stenosis/Stricture 1 1
Thrombosis 1 1
Pulmonary Emphysema 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Skin Inflammation 1 1
Nasal Obstruction 1 1
Chemosis 1 1
Pulmonary Edema 1 1
Obstruction/Occlusion 1 1
Diminished Pulse Pressure 1 1
Cardiovascular Insufficiency 1 1
Respiratory Insufficiency 1 1
Hematemesis 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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