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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

MDR Year MDR Reports MDR Events
2019 87 87
2020 113 113
2021 198 198
2022 770 770
2023 402 402
2024 361 361

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 293 293
Leak/Splash 186 186
Inflation Problem 184 184
Break 141 141
Detachment of Device or Device Component 114 114
Disconnection 81 81
Crack 74 74
Connection Problem 61 61
Defective Component 57 57
Material Split, Cut or Torn 50 50
Material Separation 48 48
Contamination /Decontamination Problem 47 47
Material Puncture/Hole 45 45
Component Missing 43 43
Fluid/Blood Leak 42 42
Device Markings/Labelling Problem 38 38
Fracture 35 35
Unintended Deflation 35 35
Separation Problem 32 32
Defective Device 28 28
Obstruction of Flow 24 24
Use of Device Problem 23 23
Incomplete or Missing Packaging 22 22
Deflation Problem 21 21
Material Deformation 20 20
Accessory Incompatible 19 19
Loose or Intermittent Connection 18 18
Insufficient Information 17 17
Decrease in Pressure 17 17
Inadequacy of Device Shape and/or Size 16 16
Device Damaged Prior to Use 16 16
Tear, Rip or Hole in Device Packaging 15 15
Material Discolored 15 15
Mechanical Problem 14 14
Fitting Problem 12 12
Pressure Problem 12 12
Difficult to Insert 12 12
Suction Problem 11 11
Material Integrity Problem 11 11
Gel Leak 11 11
Material Twisted/Bent 10 10
Moisture or Humidity Problem 10 10
Material Rupture 10 10
Patient Device Interaction Problem 10 10
Device Dislodged or Dislocated 9 9
Nonstandard Device 9 9
Material Fragmentation 9 9
Difficult to Remove 8 8
Physical Resistance/Sticking 8 8
Material Too Soft/Flexible 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1414 1414
Insufficient Information 223 223
No Consequences Or Impact To Patient 115 115
Decreased Respiratory Rate 29 29
Low Oxygen Saturation 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
Unintended Extubation 8 8
No Patient Involvement 8 8
Respiratory Insufficiency 7 7
Aspiration Pneumonitis 6 6
Hemorrhage/Bleeding 6 6
Cardiac Arrest 5 5
Bradycardia 5 5
Hypoventilation 5 5
Hypoxia 5 5
No Code Available 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Aspiration/Inhalation 4 4
Abrasion 3 3
Fever 3 3
Fistula 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Death 3 3
Laceration(s) of Esophagus 2 2
Ventilator Dependent 2 2
Respiratory Failure 2 2
Swelling/ Edema 2 2
Blister 2 2
Skin Inflammation/ Irritation 2 2
Device Embedded In Tissue or Plaque 2 2
Failure of Implant 2 2
Brain Injury 2 2
Pneumonia 2 2
Pneumothorax 2 2
Chest Pain 2 2
Chemosis 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Adult Respiratory Distress Syndrome 1 1
Wound Dehiscence 1 1
Stacking Breaths 1 1
Bruise/Contusion 1 1
Apnea 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 Smiths Medical ASD Inc. I Sep-11-2024
3 Smiths Medical ASD Inc. I Aug-23-2024
4 Smiths Medical ASD Inc. II Jun-04-2019
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