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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
A.R GUIDE IN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
  1.  K151381  Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, No ...
  2.  K223130  Shiley™ Pediatric Oral/Nasal Endotracheal Tube wit ...
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
DAVIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ETVIEW LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NEVAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECURISYN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEXMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1
ZHANJIANG STAR ENTERPRISE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1016 1016
2016 836 836
2017 812 812
2018 975 975
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 2067 2067
Use of Device Problem 1615 1615
Inflation Problem 1475 1475
Leak/Splash 812 812
Disconnection 441 441
Material Split, Cut or Torn 439 439
Defective Component 430 430
Air Leak 283 283
Deflation Problem 280 280
Connection Problem 273 273
Detachment of Device or Device Component 262 262
Device Contamination with Chemical or Other Material 233 233
Break 203 203
Device Markings/Labelling Problem 159 159
Material Puncture/Hole 142 142
Material Integrity Problem 127 127
Material Separation 118 118
Material Deformation 114 114
Obstruction of Flow 113 113
Insufficient Information 107 107
Device Operates Differently Than Expected 106 106
Material Rupture 103 103
Loose or Intermittent Connection 96 96
Appropriate Term/Code Not Available 93 93
Pressure Problem 83 83
Kinked 82 82
Crack 81 81
Material Twisted/Bent 75 75
Contamination /Decontamination Problem 73 73
Detachment Of Device Component 71 71
Fluid/Blood Leak 70 70
Deformation Due to Compressive Stress 62 62
Unintended Deflation 60 60
Human-Device Interface Problem 60 60
Labelling, Instructions for Use or Training Problem 57 57
Partial Blockage 53 53
Hole In Material 53 53
Device Packaging Compromised 51 51
Defective Device 49 49
Occlusion Within Device 47 47
Separation Problem 46 46
Mechanical Problem 45 45
Component Missing 43 43
Burst Container or Vessel 42 42
Fitting Problem 42 42
Adverse Event Without Identified Device or Use Problem 40 40
Device Damaged Prior to Use 38 38
Contamination 37 37
Inadequacy of Device Shape and/or Size 37 37
Decrease in Pressure 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2879 2879
No Patient Involvement 1559 1559
No Consequences Or Impact To Patient 1478 1478
Unintended Extubation 1316 1316
No Known Impact Or Consequence To Patient 1281 1281
Extubate 1154 1154
Insufficient Information 716 716
No Information 397 397
Low Oxygen Saturation 281 281
Hypoxia 92 92
No Code Available 81 81
Hypoventilation 74 74
Death 63 63
Unspecified Tissue Injury 61 61
Airway Obstruction 47 47
Cardiac Arrest 41 41
Hemorrhage/Bleeding 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Decreased Respiratory Rate 33 33
Respiratory Distress 30 30
Respiratory Insufficiency 29 29
Dyspnea 25 25
Injury 25 25
Bradycardia 24 24
Pneumothorax 22 22
Respiratory Failure 19 19
Aspiration/Inhalation 18 18
Swelling/ Edema 18 18
Unspecified Respiratory Problem 17 17
Respiratory Arrest 15 15
Pain 13 13
Pneumonia 13 13
Foreign Body In Patient 13 13
Patient Problem/Medical Problem 13 13
Tissue Damage 12 12
Bronchospasm 12 12
Low Blood Pressure/ Hypotension 11 11
Increased Respiratory Rate 11 11
Obstruction/Occlusion 10 10
Device Embedded In Tissue or Plaque 9 9
Complaint, Ill-Defined 9 9
Pulmonary Emphysema 9 9
Reaction 8 8
Swelling 8 8
Discomfort 7 7
Vomiting 7 7
Blood Loss 7 7
Ventilator Dependent 6 6
Granuloma 6 6
Laceration(s) 5 5

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 Parker Medical II Jul-19-2016
6 Smiths Medical ASD Inc. II Oct-27-2021
7 Stryker Sustainability Solutions II May-09-2016
8 TELEFLEX LLC I Jun-29-2023
9 TELEFLEX LLC II Jan-23-2023
10 TELEFLEX MEDICAL INC II Jul-10-2020
11 Teleflex Medical I Sep-09-2019
12 Teleflex Medical I Jun-19-2019
13 Teleflex Medical II May-29-2019
14 Teleflex Medical II Feb-09-2017
15 Teleflex Medical II Nov-09-2016
16 Teleflex Medical II Jun-09-2016
17 Teleflex Medical II Feb-10-2015
18 Teleflex Medical Europe Ltd II Aug-19-2021
19 Teleflex, Inc. II Feb-17-2015
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