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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
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 87 87
2020 113 113
2021 198 198
2022 770 770
2023 402 402
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 210 210
Leak/Splash 178 178
Inflation Problem 157 157
Break 115 115
Detachment of Device or Device Component 109 109
Connection Problem 53 53
Disconnection 52 52
Defective Component 52 52
Crack 48 48
Contamination /Decontamination Problem 47 47
Material Separation 45 45
Component Missing 41 41
Material Split, Cut or Torn 37 37
Fluid/Blood Leak 36 36
Material Puncture/Hole 33 33
Separation Problem 30 30
Device Markings/Labelling Problem 30 30
Defective Device 26 26
Obstruction of Flow 23 23
Use of Device Problem 23 23
Unintended Deflation 22 22
Incomplete or Missing Packaging 21 21
Material Deformation 20 20
Accessory Incompatible 19 19
Fracture 17 17
Device Damaged Prior to Use 16 16
Insufficient Information 16 16
Tear, Rip or Hole in Device Packaging 15 15
Deflation Problem 15 15
Material Discolored 14 14
Loose or Intermittent Connection 13 13
Mechanical Problem 12 12
Decrease in Pressure 12 12
Pressure Problem 12 12
Gel Leak 11 11
Suction Problem 10 10
Inadequacy of Device Shape and/or Size 10 10
Material Integrity Problem 10 10
Moisture or Humidity Problem 10 10
Material Twisted/Bent 9 9
Patient Device Interaction Problem 9 9
Difficult to Insert 9 9
Nonstandard Device 9 9
Material Fragmentation 8 8
Difficult to Remove 8 8
Material Too Soft/Flexible 7 7
Device Dislodged or Dislocated 7 7
Deformation Due to Compressive Stress 7 7
Expiration Date Error 6 6
Complete Blockage 6 6
Degraded 5 5
Labelling, Instructions for Use or Training Problem 5 5
Material Rupture 5 5
Problem with Sterilization 5 5
Human-Device Interface Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Packaging Problem 5 5
Premature Separation 4 4
Physical Resistance/Sticking 4 4
Optical Discoloration 4 4
Separation Failure 4 4
Unsealed Device Packaging 4 4
Product Quality Problem 4 4
Component Incompatible 3 3
Tidal Volume Fluctuations 3 3
Failure to Deliver 3 3
No Pressure 3 3
Sharp Edges 3 3
Positioning Problem 3 3
Appropriate Term/Code Not Available 2 2
Incomplete or Inadequate Connection 2 2
Unexpected Color 2 2
Failure to Deflate 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Jam 2 2
Blocked Connection 2 2
Difficult to Advance 2 2
Dull, Blunt 2 2
Material Perforation 2 2
Structural Problem 2 2
Malposition of Device 2 2
Insufficient Flow or Under Infusion 2 2
Improper or Incorrect Procedure or Method 2 2
Moisture Damage 2 2
Shipping Damage or Problem 2 2
Material Too Rigid or Stiff 2 2
Partial Blockage 2 2
Unable to Obtain Readings 2 2
Device Difficult to Setup or Prepare 2 2
Melted 1 1
Migration or Expulsion of Device 1 1
Device Appears to Trigger Rejection 1 1
Incorrect Measurement 1 1
Loss of or Failure to Bond 1 1
Device Alarm System 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Positioning Failure 1 1
Decoupling 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1125 1125
Insufficient Information 190 190
No Consequences Or Impact To Patient 115 115
Decreased Respiratory Rate 29 29
Low Oxygen Saturation 28 28
Extubate 20 20
Airway Obstruction 19 19
No Information 19 19
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 8 8
Unintended Extubation 8 8
Dyspnea 8 8
Hemorrhage/Bleeding 6 6
Aspiration Pneumonitis 6 6
No Code Available 5 5
Respiratory Insufficiency 5 5
Bradycardia 5 5
Hypoxia 5 5
Cardiac Arrest 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Hypoventilation 3 3
Abrasion 3 3
Death 3 3
Fistula 3 3
Fever 2 2
Aspiration/Inhalation 2 2
Failure of Implant 2 2
Pneumonia 2 2
Pneumothorax 2 2
Brain Injury 2 2
Respiratory Failure 2 2
Device Embedded In Tissue or Plaque 2 2
Laceration(s) of Esophagus 2 2
Swelling/ Edema 2 2
Blister 2 2
Skin Inflammation/ Irritation 1 1
Hematemesis 1 1
Salivary Hypersecretion 1 1
Stomatitis 1 1
Urethral Stenosis/Stricture 1 1
Myocardial Hypertrophy 1 1
Respiratory Arrest 1 1
Hypovolemic Shock 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Discomfort 1 1
Injury 1 1
Ventilator Dependent 1 1
Sore Throat 1 1
Obstruction/Occlusion 1 1
Forced Expiratory Volume Decreased 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Respiratory Distress 1 1
Swelling 1 1
Thrombosis 1 1
Infiltration into Tissue 1 1
Perforation 1 1
Adult Respiratory Distress Syndrome 1 1
Chemosis 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 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
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