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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
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 524 524

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 1874 1874
Use of Device Problem 1423 1423
Inflation Problem 507 507
Defective Component 390 390
Material Split, Cut or Torn 372 372
Leak/Splash 359 359
Disconnection 236 236
Detachment of Device or Device Component 183 183
Connection Problem 176 176
Deflation Problem 130 130
Material Puncture/Hole 112 112
Material Integrity Problem 90 90
Break 83 83
Obstruction of Flow 80 80
Material Separation 76 76
Insufficient Information 73 73
Contamination /Decontamination Problem 70 70
Material Deformation 68 68
Appropriate Term/Code Not Available 66 66
Loose or Intermittent Connection 63 63
Device Markings/Labelling Problem 62 62
Material Rupture 58 58
Unintended Deflation 56 56
Deformation Due to Compressive Stress 55 55
Material Twisted/Bent 55 55
Pressure Problem 53 53
Labelling, Instructions for Use or Training Problem 52 52
Fluid/Blood Leak 51 51
Crack 50 50
Separation Problem 46 46
Human-Device Interface Problem 35 35
Mechanical Problem 33 33
Defective Device 30 30
Patient-Device Incompatibility 28 28
Component Missing 22 22
Adverse Event Without Identified Device or Use Problem 20 20
Decrease in Pressure 20 20
Fracture 19 19
Physical Resistance/Sticking 19 19
Component Incompatible 18 18
Burst Container or Vessel 16 16
Partial Blockage 16 16
Delivered as Unsterile Product 16 16
Inadequacy of Device Shape and/or Size 16 16
Material Too Rigid or Stiff 15 15
Material Fragmentation 15 15
Malposition of Device 15 15
Tear, Rip or Hole in Device Packaging 14 14
Fitting Problem 14 14
Difficult to Remove 12 12
Gel Leak 12 12
Device Dislodged or Dislocated 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Device Damaged Prior to Use 11 11
Unsealed Device Packaging 11 11
Peeled/Delaminated 11 11
Difficult to Insert 11 11
Complete Blockage 10 10
Failure to Deflate 10 10
Suction Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Patient Device Interaction Problem 9 9
Structural Problem 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Nonstandard Device 8 8
Off-Label Use 8 8
Tidal Volume Fluctuations 7 7
Product Quality Problem 7 7
Migration or Expulsion of Device 7 7
Improper Flow or Infusion 7 7
Output Problem 6 6
Separation Failure 6 6
Improper or Incorrect Procedure or Method 6 6
Material Too Soft/Flexible 6 6
Infusion or Flow Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Ventilation Problem in Device Environment 4 4
Mechanical Jam 4 4
Failure to Disconnect 4 4
Blocked Connection 4 4
Increase in Pressure 4 4
Loss of or Failure to Bond 4 4
Device Alarm System 4 4
False Alarm 4 4
Contamination 4 4
Entrapment of Device 4 4
Illegible Information 4 4
Missing Information 4 4
No Flow 3 3
Explosion 3 3
Unintended Ejection 3 3
Material Invagination 3 3
Degraded 3 3
Material Discolored 3 3
Collapse 3 3
Insufficient Flow or Under Infusion 3 3
Material Perforation 3 3
Device Slipped 3 3
Contamination of Device Ingredient or Reagent 3 3
Dent in Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2494 2494
Unintended Extubation 1155 1155
Extubate 692 692
Insufficient Information 663 663
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 232 232
No Information 176 176
Unspecified Tissue Injury 60 60
Hypoventilation 60 60
Hypoxia 57 57
Airway Obstruction 39 39
Decreased Respiratory Rate 31 31
Cardiac Arrest 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Death 28 28
Respiratory Insufficiency 27 27
Hemorrhage/Bleeding 26 26
Injury 20 20
Pneumothorax 19 19
Unspecified Respiratory Problem 17 17
Respiratory Failure 16 16
Respiratory Arrest 15 15
No Code Available 14 14
Dyspnea 14 14
Bradycardia 14 14
Swelling/ Edema 13 13
Bronchospasm 12 12
Aspiration/Inhalation 11 11
Respiratory Distress 10 10
Foreign Body In Patient 10 10
Obstruction/Occlusion 9 9
Pain 8 8
Tissue Damage 7 7
Increased Respiratory Rate 7 7
Pneumonia 6 6
Swelling 6 6
Pulmonary Emphysema 6 6
Granuloma 6 6
Low Blood Pressure/ Hypotension 5 5
Tachycardia 5 5
Patient Problem/Medical Problem 5 5
Device Embedded In Tissue or Plaque 5 5
Wheezing 4 4
Ventilator Dependent 4 4
Reaction 4 4
Discomfort 4 4
Adult Respiratory Distress Syndrome 4 4
Apnea 3 3
Bronchitis 3 3
Laceration(s) 3 3
Ulcer 3 3
Forced Expiratory Volume Increased 3 3
Post Traumatic Wound Infection 3 3
Respiratory Acidosis 2 2
Anxiety 2 2
Distress 2 2
Complaint, Ill-Defined 2 2
Pulmonary Edema 2 2
Vomiting 2 2
Anaphylactoid 2 2
Necrosis 2 2
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 2 2
Erythema 2 2
Edema 2 2
Dysphagia/ Odynophagia 2 2
Stacking Breaths 2 2
Abrasion 2 2
Asystole 2 2
Localized Skin Lesion 2 2
Skin Inflammation/ Irritation 2 2
Unintended Radiation Exposure 2 2
Fluid Discharge 2 2
Blood Loss 1 1
Test Result 1 1
Convulsion/Seizure 1 1
Aphonia 1 1
Ischemia Stroke 1 1
Multiple Fractures 1 1
Abscess 1 1
Abnormal Blood Gases 1 1
Arrhythmia 1 1
Asthma 1 1
Cardiopulmonary Arrest 1 1
Cellulitis 1 1
Chest Pain 1 1
Cyanosis 1 1
Cardiac Enzyme Elevation 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Occlusion 1 1
Burning Sensation 1 1
Therapeutic Effects, Unexpected 1 1
Paresis 1 1
Perforation 1 1
Pleural Effusion 1 1
Respiratory Distress Syndrome of Newborns 1 1

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 Smiths Medical ASD Inc. II Oct-27-2021
5 TELEFLEX LLC I Jun-29-2023
6 TELEFLEX LLC II Jan-23-2023
7 TELEFLEX MEDICAL INC II Jul-10-2020
8 Teleflex Medical I Sep-09-2019
9 Teleflex Medical I Jun-19-2019
10 Teleflex Medical II May-29-2019
11 Teleflex Medical Europe Ltd II Aug-19-2021
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