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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 1139 1139

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 2029 2029
Use of Device Problem 1609 1609
Inflation Problem 533 533
Material Split, Cut or Torn 420 420
Defective Component 417 417
Leak/Splash 379 379
Disconnection 258 258
Connection Problem 186 186
Detachment of Device or Device Component 185 185
Deflation Problem 139 139
Material Puncture/Hole 115 115
Material Integrity Problem 98 98
Obstruction of Flow 94 94
Break 87 87
Insufficient Information 79 79
Material Separation 78 78
Appropriate Term/Code Not Available 77 77
Contamination /Decontamination Problem 72 72
Material Rupture 69 69
Material Deformation 68 68
Material Twisted/Bent 68 68
Device Markings/Labelling Problem 66 66
Loose or Intermittent Connection 64 64
Unintended Deflation 60 60
Labelling, Instructions for Use or Training Problem 56 56
Deformation Due to Compressive Stress 56 56
Crack 55 55
Pressure Problem 53 53
Fluid/Blood Leak 52 52
Separation Problem 46 46
Human-Device Interface Problem 38 38
Mechanical Problem 37 37
Defective Device 32 32
Patient-Device Incompatibility 28 28
Component Missing 23 23
Physical Resistance/Sticking 22 22
Inadequacy of Device Shape and/or Size 22 22
Decrease in Pressure 20 20
Adverse Event Without Identified Device or Use Problem 20 20
Fracture 19 19
Partial Blockage 18 18
Material Too Rigid or Stiff 18 18
Component Incompatible 18 18
Burst Container or Vessel 16 16
Delivered as Unsterile Product 16 16
Fitting Problem 16 16
Material Fragmentation 16 16
Malposition of Device 15 15
Patient Device Interaction Problem 14 14
Tear, Rip or Hole in Device Packaging 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2877 2877
Unintended Extubation 1316 1316
Insufficient Information 716 716
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 250 250
No Information 176 176
Hypoventilation 71 71
Unspecified Tissue Injury 61 61
Hypoxia 61 61
Airway Obstruction 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Cardiac Arrest 33 33
Decreased Respiratory Rate 32 32
Hemorrhage/Bleeding 32 32
Respiratory Insufficiency 29 29
Death 28 28
Pneumothorax 20 20
Injury 20 20
Swelling/ Edema 18 18
Respiratory Failure 17 17
Unspecified Respiratory Problem 17 17
Dyspnea 16 16
Respiratory Arrest 15 15
Bradycardia 15 15
No Code Available 14 14
Pain 12 12
Bronchospasm 12 12
Aspiration/Inhalation 11 11
Respiratory Distress 10 10
Foreign Body In Patient 10 10
Pneumonia 9 9
Obstruction/Occlusion 9 9
Pulmonary Emphysema 8 8
Increased Respiratory Rate 8 8
Tissue Damage 7 7
Granuloma 6 6
Swelling 6 6
Low Blood Pressure/ Hypotension 5 5
Wheezing 5 5
Device Embedded In Tissue or Plaque 5 5
Tachycardia 5 5
Patient Problem/Medical Problem 5 5
Reaction 4 4
Discomfort 4 4
Adult Respiratory Distress Syndrome 4 4
Ventilator Dependent 4 4
Post Traumatic Wound Infection 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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