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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
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K233713  Pilling Tracheostomy Tubes
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 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 251 251
Leak/Splash 185 185
Inflation Problem 175 175
Break 123 123
Detachment of Device or Device Component 113 113
Crack 68 68
Disconnection 55 55
Defective Component 55 55
Connection Problem 54 54
Contamination /Decontamination Problem 47 47
Material Separation 46 46
Component Missing 43 43
Material Puncture/Hole 42 42
Material Split, Cut or Torn 41 41
Fluid/Blood Leak 39 39
Fracture 34 34
Device Markings/Labelling Problem 34 34
Separation Problem 32 32
Unintended Deflation 26 26
Defective Device 26 26
Obstruction of Flow 24 24
Use of Device Problem 23 23
Incomplete or Missing Packaging 22 22
Deflation Problem 20 20
Material Deformation 20 20
Accessory Incompatible 19 19
Decrease in Pressure 17 17
Device Damaged Prior to Use 16 16
Insufficient Information 16 16
Tear, Rip or Hole in Device Packaging 15 15
Material Discolored 15 15
Loose or Intermittent Connection 15 15
Mechanical Problem 12 12
Inadequacy of Device Shape and/or Size 12 12
Pressure Problem 12 12
Material Integrity Problem 11 11
Suction Problem 11 11
Gel Leak 11 11
Material Twisted/Bent 10 10
Moisture or Humidity Problem 10 10
Patient Device Interaction Problem 10 10
Material Fragmentation 9 9
Difficult to Insert 9 9
Nonstandard Device 9 9
Difficult to Remove 8 8
Material Rupture 8 8
Degraded 7 7
Material Too Soft/Flexible 7 7
Physical Resistance/Sticking 7 7
Device Dislodged or Dislocated 7 7
Deformation Due to Compressive Stress 7 7
Expiration Date Error 6 6
Incomplete or Inadequate Connection 6 6
Complete Blockage 6 6
Labelling, Instructions for Use or Training Problem 5 5
Problem with Sterilization 5 5
Human-Device Interface Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Packaging Problem 5 5
No Pressure 4 4
Optical Discoloration 4 4
Separation Failure 4 4
Premature Separation 4 4
Product Quality Problem 4 4
Unsealed Device Packaging 4 4
Component Incompatible 3 3
Partial Blockage 3 3
Tidal Volume Fluctuations 3 3
Insufficient Flow or Under Infusion 3 3
Failure to Deliver 3 3
Sharp Edges 3 3
Scratched Material 3 3
Positioning Problem 3 3
Difficult to Advance 2 2
Mechanical Jam 2 2
Blocked Connection 2 2
Appropriate Term/Code Not Available 2 2
Unexpected Color 2 2
Failure to Deflate 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Perforation 2 2
Device Contamination with Body Fluid 2 2
Dull, Blunt 2 2
Structural Problem 2 2
Malposition of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Unable to Obtain Readings 2 2
Material Too Rigid or Stiff 2 2
Shipping Damage or Problem 2 2
Device Difficult to Setup or Prepare 2 2
Misconnection 2 2
Moisture Damage 2 2
Melted 1 1
Migration or Expulsion of Device 1 1
Pumping Stopped 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1252 1252
Insufficient Information 219 219
No Consequences Or Impact To Patient 115 115
Low Oxygen Saturation 29 29
Decreased Respiratory Rate 29 29
Extubate 20 20
No Information 19 19
Airway Obstruction 19 19
No Known Impact Or Consequence To Patient 13 13
Dyspnea 9 9
No Patient Involvement 8 8
Unintended Extubation 8 8
Respiratory Insufficiency 7 7
Aspiration Pneumonitis 6 6
Hemorrhage/Bleeding 6 6
Bradycardia 5 5
Hypoxia 5 5
No Code Available 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hypoventilation 4 4
Cardiac Arrest 4 4
Abrasion 3 3
Death 3 3
Fistula 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Device Embedded In Tissue or Plaque 2 2
Respiratory Failure 2 2
Ventilator Dependent 2 2
Laceration(s) of Esophagus 2 2
Swelling/ Edema 2 2
Blister 2 2
Failure of Implant 2 2
Brain Injury 2 2
Pneumonia 2 2
Pneumothorax 2 2
Aspiration/Inhalation 2 2
Fever 2 2
Chest Pain 2 2
Wound Dehiscence 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Adult Respiratory Distress Syndrome 1 1
Chemosis 1 1
Bruise/Contusion 1 1
Respiratory Distress 1 1
Swelling 1 1
Thrombosis 1 1
Discomfort 1 1
Injury 1 1
Infiltration into Tissue 1 1
Pain 1 1
Perforation 1 1
Hypovolemic Shock 1 1
Skin Inflammation/ Irritation 1 1
Myocardial Hypertrophy 1 1
Respiratory Arrest 1 1
Hematemesis 1 1
Salivary Hypersecretion 1 1
Stomatitis 1 1
Urethral Stenosis/Stricture 1 1
Sore Throat 1 1
Obstruction/Occlusion 1 1
Forced Expiratory Volume Decreased 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Blood Loss 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
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