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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
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K192511  Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, ...

MDR Year MDR Reports MDR Events
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 224 224
Leak/Splash 180 180
Inflation Problem 164 164
Break 117 117
Detachment of Device or Device Component 110 110
Disconnection 54 54
Defective Component 53 53
Connection Problem 53 53
Crack 52 52
Contamination /Decontamination Problem 47 47
Material Separation 46 46
Component Missing 42 42
Material Split, Cut or Torn 38 38
Material Puncture/Hole 37 37
Fluid/Blood Leak 36 36
Device Markings/Labelling Problem 32 32
Separation Problem 31 31
Defective Device 26 26
Unintended Deflation 24 24
Obstruction of Flow 23 23
Use of Device Problem 23 23
Fracture 22 22
Incomplete or Missing Packaging 21 21
Material Deformation 20 20
Accessory Incompatible 19 19
Deflation Problem 17 17
Device Damaged Prior to Use 16 16
Insufficient Information 16 16
Tear, Rip or Hole in Device Packaging 15 15
Loose or Intermittent Connection 15 15
Material Discolored 14 14
Mechanical Problem 12 12
Inadequacy of Device Shape and/or Size 12 12
Decrease in Pressure 12 12
Pressure Problem 12 12
Gel Leak 11 11
Suction Problem 10 10
Material Integrity Problem 10 10
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 7 7
Degraded 7 7
Material Too Soft/Flexible 7 7
Device Dislodged or Dislocated 7 7
Deformation Due to Compressive Stress 7 7
Complete Blockage 6 6
Expiration Date Error 6 6
Problem with Sterilization 5 5
Labelling, Instructions for Use or Training Problem 5 5
Human-Device Interface Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Packaging Problem 5 5
Physical Resistance/Sticking 5 5
Premature Separation 4 4
No Pressure 4 4
Optical Discoloration 4 4
Separation Failure 4 4
Unsealed Device Packaging 4 4
Product Quality Problem 4 4
Component Incompatible 3 3
Partial Blockage 3 3
Tidal Volume Fluctuations 3 3
Failure to Deliver 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
Blocked Connection 2 2
Difficult to Advance 2 2
Mechanical Jam 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
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 1166 1166
Insufficient Information 202 202
No Consequences Or Impact To Patient 115 115
Decreased Respiratory Rate 29 29
Low Oxygen Saturation 28 28
Extubate 20 20
No Information 19 19
Airway Obstruction 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
Fistula 3 3
Abrasion 3 3
Death 3 3
Hypoventilation 3 3
Ventilator Dependent 2 2
Brain Injury 2 2
Failure of Implant 2 2
Pneumonia 2 2
Pneumothorax 2 2
Fever 2 2
Aspiration/Inhalation 2 2
Laceration(s) of Esophagus 2 2
Respiratory Failure 2 2
Device Embedded In Tissue or Plaque 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
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Obstruction/Occlusion 1 1
Forced Expiratory Volume Decreased 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Adult Respiratory Distress Syndrome 1 1
Chemosis 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Wound Dehiscence 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Swelling 1 1
Thrombosis 1 1
Infiltration into Tissue 1 1
Pain 1 1
Perforation 1 1
Discomfort 1 1
Injury 1 1
Sore Throat 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
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