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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 1321 1321

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 2082 2082
Use of Device Problem 1658 1658
Inflation Problem 545 545
Material Split, Cut or Torn 432 432
Defective Component 426 426
Leak/Splash 385 385
Disconnection 260 260
Connection Problem 192 192
Detachment of Device or Device Component 185 185
Deflation Problem 146 146
Material Puncture/Hole 116 116
Material Integrity Problem 103 103
Obstruction of Flow 95 95
Break 87 87
Material Separation 79 79
Insufficient Information 79 79
Appropriate Term/Code Not Available 78 78
Contamination /Decontamination Problem 75 75
Material Twisted/Bent 69 69
Material Rupture 69 69
Material Deformation 68 68
Device Markings/Labelling Problem 66 66
Loose or Intermittent Connection 65 65
Unintended Deflation 61 61
Crack 57 57
Labelling, Instructions for Use or Training Problem 56 56
Deformation Due to Compressive Stress 56 56
Pressure Problem 53 53
Fluid/Blood Leak 52 52
Separation Problem 46 46
Human-Device Interface Problem 41 41
Mechanical Problem 37 37
Defective Device 32 32
Patient-Device Incompatibility 28 28
Physical Resistance/Sticking 25 25
Component Missing 23 23
Decrease in Pressure 22 22
Inadequacy of Device Shape and/or Size 22 22
Material Too Rigid or Stiff 21 21
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 16 16
Material Fragmentation 16 16
Fitting Problem 16 16
Delivered as Unsterile Product 16 16
Malposition of Device 15 15
Tear, Rip or Hole in Device Packaging 14 14
Patient Device Interaction Problem 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2988 2988
Unintended Extubation 1363 1363
Insufficient Information 735 735
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 255 255
No Information 176 176
Hypoventilation 74 74
Unspecified Tissue Injury 62 62
Hypoxia 62 62
Airway Obstruction 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Cardiac Arrest 33 33
Decreased Respiratory Rate 32 32
Hemorrhage/Bleeding 32 32
Respiratory Insufficiency 31 31
Death 28 28
Injury 20 20
Pneumothorax 20 20
Swelling/ Edema 19 19
Dyspnea 17 17
Respiratory Failure 17 17
Unspecified Respiratory Problem 17 17
Bradycardia 15 15
Respiratory Arrest 15 15
No Code Available 14 14
Pain 12 12
Bronchospasm 12 12
Aspiration/Inhalation 11 11
Foreign Body In Patient 11 11
Respiratory Distress 10 10
Obstruction/Occlusion 9 9
Pneumonia 9 9
Pulmonary Emphysema 8 8
Increased Respiratory Rate 8 8
Tissue Damage 7 7
Granuloma 6 6
Low Blood Pressure/ Hypotension 6 6
Tachycardia 6 6
Swelling 6 6
Wheezing 5 5
Ventilator Dependent 5 5
Patient Problem/Medical Problem 5 5
Device Embedded In Tissue or Plaque 5 5
Adult Respiratory Distress Syndrome 4 4
Discomfort 4 4
Reaction 4 4
Ulcer 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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