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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)
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
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECURISYN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEXMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1379 1379
2020 1070 1070
2021 1329 1329
2022 1132 1132
2023 1331 1331
2024 1555 1555

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 2140 2140
Use of Device Problem 1716 1716
Inflation Problem 554 554
Material Split, Cut or Torn 451 451
Defective Component 434 434
Leak/Splash 389 389
Disconnection 270 270
Connection Problem 195 195
Detachment of Device or Device Component 186 186
Deflation Problem 153 153
Material Puncture/Hole 118 118
Material Integrity Problem 107 107
Obstruction of Flow 95 95
Break 87 87
Material Twisted/Bent 85 85
Appropriate Term/Code Not Available 81 81
Insufficient Information 80 80
Material Separation 80 80
Contamination /Decontamination Problem 75 75
Material Rupture 70 70
Device Markings/Labelling Problem 68 68
Material Deformation 68 68
Loose or Intermittent Connection 66 66
Unintended Deflation 63 63
Crack 58 58
Labelling, Instructions for Use or Training Problem 57 57
Deformation Due to Compressive Stress 56 56
Pressure Problem 53 53
Fluid/Blood Leak 52 52
Separation Problem 46 46
Human-Device Interface Problem 43 43
Mechanical Problem 37 37
Defective Device 32 32
Patient-Device Incompatibility 29 29
Physical Resistance/Sticking 25 25
Inadequacy of Device Shape and/or Size 23 23
Decrease in Pressure 23 23
Component Missing 23 23
Material Too Rigid or Stiff 22 22
Adverse Event Without Identified Device or Use Problem 20 20
Fracture 19 19
Component Incompatible 19 19
Partial Blockage 18 18
Burst Container or Vessel 18 18
Delivered as Unsterile Product 16 16
Material Fragmentation 16 16
Fitting Problem 16 16
Patient Device Interaction Problem 15 15
Difficult to Remove 15 15
Malposition of Device 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3137 3137
Unintended Extubation 1404 1404
Insufficient Information 764 764
Extubate 692 692
No Consequences Or Impact To Patient 648 648
No Patient Involvement 504 504
No Known Impact Or Consequence To Patient 283 283
Low Oxygen Saturation 266 266
No Information 176 176
Hypoventilation 78 78
Unspecified Tissue Injury 65 65
Hypoxia 65 65
Airway Obstruction 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Hemorrhage/Bleeding 36 36
Cardiac Arrest 34 34
Decreased Respiratory Rate 32 32
Respiratory Insufficiency 31 31
Death 28 28
Injury 20 20
Pneumothorax 20 20
Swelling/ Edema 19 19
Dyspnea 18 18
Bradycardia 18 18
Unspecified Respiratory Problem 17 17
Respiratory Failure 17 17
Respiratory Arrest 15 15
No Code Available 14 14
Foreign Body In Patient 13 13
Pain 12 12
Bronchospasm 12 12
Aspiration/Inhalation 11 11
Pneumonia 11 11
Respiratory Distress 10 10
Obstruction/Occlusion 9 9
Low Blood Pressure/ Hypotension 9 9
Pulmonary Emphysema 8 8
Increased Respiratory Rate 8 8
Tissue Damage 7 7
Swelling 6 6
Granuloma 6 6
Tachycardia 6 6
Wheezing 5 5
Device Embedded In Tissue or Plaque 5 5
Patient Problem/Medical Problem 5 5
Ventilator Dependent 5 5
Discomfort 4 4
Reaction 4 4
Adult Respiratory Distress Syndrome 4 4
Apnea 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation I Jul-30-2019
2 Covidien II Apr-01-2023
3 Flexicare Medical Ltd. I Nov-26-2020
4 MEDLINE INDUSTRIES, LP - Northfield I May-28-2024
5 Smiths Medical ASD Inc. II Oct-27-2021
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 I Sep-09-2019
10 Teleflex Medical I Jun-19-2019
11 Teleflex Medical II May-29-2019
12 Teleflex Medical Europe Ltd II Aug-19-2021
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