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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 ...
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 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 229 229
Leak/Splash 223 223
Inflation Problem 192 192
Break 133 133
Detachment of Device or Device Component 113 113
Crack 59 59
Disconnection 56 56
Defective Component 56 56
Connection Problem 55 55
Air Leak 52 52
Contamination /Decontamination Problem 47 47
Component Missing 46 46
Material Separation 46 46
Fluid/Blood Leak 40 40
Material Split, Cut or Torn 40 40
Material Puncture/Hole 38 38
Device Markings/Labelling Problem 32 32
Separation Problem 31 31
Defective Device 28 28
Fracture 26 26
Obstruction of Flow 24 24
Material Integrity Problem 24 24
Unintended Deflation 24 24
Material Deformation 23 23
Deflation Problem 23 23
Decrease in Pressure 23 23
Use of Device Problem 23 23
Device Damaged Prior to Use 22 22
Incomplete or Missing Packaging 21 21
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 14 14
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
Moisture or Humidity Problem 10 10
Material Twisted/Bent 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
Noise, Audible 7 7
Physical Resistance/Sticking 6 6
Complete Blockage 6 6
Expiration Date Error 6 6
Material Perforation 6 6
Device Operates Differently Than Expected 6 6
Torn Material 6 6
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
Positioning Problem 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
Separation Failure 4 4
Contamination of Device Ingredient or Reagent 4 4
Malposition of Device 3 3
Patient-Device Incompatibility 3 3
Insufficient Flow or Under Infusion 3 3
Fitting Problem 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
Sharp Edges 3 3
Inaccurate Information 3 3
Unexpected Color 2 2
Failure to Deflate 2 2
Incomplete or Inadequate Connection 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 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
Compatibility Problem 2 2
Mechanical Jam 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1166 1166
No Consequences Or Impact To Patient 270 270
Insufficient Information 202 202
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 13 13
No Code Available 12 12
Hemorrhage/Bleeding 10 10
Unintended Extubation 8 8
Death 7 7
Foreign Body In Patient 7 7
Discomfort 7 7
Aspiration/Inhalation 6 6
Bradycardia 6 6
Hypoxia 6 6
Aspiration Pneumonitis 6 6
Hypoventilation 5 5
Pneumothorax 5 5
Cardiac Arrest 5 5
Respiratory Insufficiency 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 3 3
Blood Loss 3 3
Respiratory Distress 3 3
Tissue Damage 3 3
Abrasion 3 3
Pneumonia 3 3
Pain 3 3
Fistula 3 3
Failure of Implant 2 2
Irritation 2 2
Fever 2 2
Apnea 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
Respiratory Failure 2 2
Device Embedded In Tissue or Plaque 2 2
Swelling/ Edema 2 2
Blister 2 2
Laceration(s) of Esophagus 2 2
Skin Inflammation/ Irritation 1 1
Respiratory Arrest 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
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
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

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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