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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 119 119

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 235 235
Leak/Splash 180 180
Inflation Problem 170 170
Break 117 117
Detachment of Device or Device Component 110 110
Defective Component 55 55
Disconnection 54 54
Connection Problem 53 53
Crack 52 52
Contamination /Decontamination Problem 47 47
Material Separation 46 46
Component Missing 43 43
Material Split, Cut or Torn 40 40
Material Puncture/Hole 39 39
Fluid/Blood Leak 36 36
Device Markings/Labelling Problem 33 33
Separation Problem 31 31
Fracture 29 29
Defective Device 26 26
Unintended Deflation 25 25
Obstruction of Flow 24 24
Use of Device Problem 23 23
Incomplete or Missing Packaging 22 22
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
Material Discolored 15 15
Loose or Intermittent Connection 15 15
Decrease in Pressure 14 14
Inadequacy of Device Shape and/or Size 12 12
Mechanical Problem 12 12
Pressure Problem 12 12
Gel Leak 11 11
Suction Problem 10 10
Patient Device Interaction Problem 10 10
Material Integrity Problem 10 10
Material Twisted/Bent 10 10
Moisture or Humidity 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
Device Dislodged or Dislocated 7 7
Deformation Due to Compressive Stress 7 7
Material Too Soft/Flexible 7 7
Physical Resistance/Sticking 6 6
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
No Pressure 4 4
Optical Discoloration 4 4
Separation Failure 4 4
Premature Separation 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
Insufficient Flow or Under Infusion 3 3
Sharp Edges 3 3
Failure to Deliver 3 3
Positioning Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Jam 2 2
Blocked Connection 2 2
Difficult to Advance 2 2
Incomplete or Inadequate Connection 2 2
Appropriate Term/Code Not Available 2 2
Unexpected Color 2 2
Failure to Deflate 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
Structural Problem 2 2
Malposition of Device 2 2
Dull, Blunt 2 2
Material Perforation 2 2
Device Contamination with Body Fluid 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1194 1194
Insufficient Information 209 209
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
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
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Fistula 3 3
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
Fever 2 2
Aspiration/Inhalation 2 2
Ventilator Dependent 2 2
Brain Injury 2 2
Failure of Implant 2 2
Pneumonia 2 2
Pneumothorax 2 2
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
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
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
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

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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