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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheal (w/wo connector)
Regulation Description Tracheal tube.
Product CodeBTR
Regulation Number 868.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
BRYAN MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1070 1070
2021 1329 1329
2022 1132 1132
2023 1331 1331
2024 1678 1678
2025 911 911

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 2264 2264
Use of Device Problem 1844 1844
Material Split, Cut or Torn 498 498
Inflation Problem 419 419
Defective Component 340 340
Disconnection 293 293
Leak/Splash 259 259
Connection Problem 190 190
Deflation Problem 149 149
Material Puncture/Hole 114 114
Material Integrity Problem 108 108
Detachment of Device or Device Component 107 107
Material Twisted/Bent 101 101
Material Rupture 86 86
Obstruction of Flow 82 82
Break 77 77
Insufficient Information 75 75
Unintended Deflation 72 72
Labelling, Instructions for Use or Training Problem 66 66
Fluid/Blood Leak 66 66
Appropriate Term/Code Not Available 63 63
Material Separation 58 58
Crack 54 54
Device Markings/Labelling Problem 52 52
Human-Device Interface Problem 47 47
Separation Problem 46 46
Contamination /Decontamination Problem 43 43
Deformation Due to Compressive Stress 41 41
Mechanical Problem 40 40
Pressure Problem 35 35
Defective Device 33 33
Material Deformation 30 30
Patient-Device Incompatibility 30 30
Physical Resistance/Sticking 25 25
Component Missing 25 25
Material Too Rigid or Stiff 23 23
Loose or Intermittent Connection 20 20
Component Incompatible 19 19
Inadequacy of Device Shape and/or Size 18 18
Decrease in Pressure 17 17
Tear, Rip or Hole in Device Packaging 16 16
Failure to Disconnect 16 16
Delivered as Unsterile Product 16 16
Burst Container or Vessel 16 16
Partial Blockage 15 15
Fitting Problem 15 15
Failure to Deflate 15 15
Fracture 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Difficult to Remove 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3783 3783
Unintended Extubation 1704 1704
Insufficient Information 863 863
Extubate 335 335
No Consequences Or Impact To Patient 292 292
Low Oxygen Saturation 290 290
No Patient Involvement 170 170
Hypoventilation 105 105
No Known Impact Or Consequence To Patient 82 82
No Information 75 75
Unspecified Tissue Injury 72 72
Hypoxia 63 63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
Airway Obstruction 44 44
Cardiac Arrest 37 37
Hemorrhage/Bleeding 35 35
Decreased Respiratory Rate 33 33
Respiratory Insufficiency 32 32
Dyspnea 24 24
Swelling/ Edema 21 21
Unspecified Respiratory Problem 18 18
Respiratory Failure 18 18
Bradycardia 17 17
Respiratory Arrest 16 16
Pain 16 16
Pneumonia 14 14
Foreign Body In Patient 13 13
Aspiration/Inhalation 12 12
Pneumothorax 10 10
Death 10 10
Low Blood Pressure/ Hypotension 9 9
Obstruction/Occlusion 9 9
Injury 9 9
Adult Respiratory Distress Syndrome 7 7
Increased Respiratory Rate 7 7
Pulmonary Emphysema 7 7
Tachycardia 7 7
Discomfort 7 7
Respiratory Distress 6 6
No Code Available 5 5
Wheezing 5 5
Laceration(s) 5 5
Ventilator Dependent 5 5
Bronchospasm 4 4
Device Embedded In Tissue or Plaque 4 4
Ulcer 3 3
Convulsion/Seizure 3 3
Vomiting 3 3
Swelling 3 3
Bronchitis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Covidien II Apr-01-2023
2 Flexicare Medical Ltd. I Nov-26-2020
3 MEDLINE INDUSTRIES, LP - Northfield I May-28-2024
4 Smiths Medical ASD Inc. II Oct-27-2021
5 Smiths Medical ASD, Inc. I Mar-12-2025
6 TELEFLEX LLC I Jun-29-2023
7 TELEFLEX LLC II Jan-23-2023
8 TELEFLEX MEDICAL INC II Jul-10-2020
9 Teleflex Medical Europe Ltd II Aug-19-2021
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