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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 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 1784 1784
Use of Device Problem 1317 1317
Inflation Problem 492 492
Defective Component 378 378
Material Split, Cut or Torn 350 350
Leak/Splash 349 349
Disconnection 227 227
Detachment of Device or Device Component 170 170
Connection Problem 159 159
Deflation Problem 127 127
Material Puncture/Hole 94 94
Material Integrity Problem 84 84
Break 82 82
Obstruction of Flow 77 77
Insufficient Information 73 73
Contamination /Decontamination Problem 70 70
Material Separation 68 68
Material Deformation 65 65
Loose or Intermittent Connection 63 63
Appropriate Term/Code Not Available 62 62
Device Markings/Labelling Problem 61 61
Material Rupture 57 57
Pressure Problem 53 53
Deformation Due to Compressive Stress 51 51
Material Twisted/Bent 49 49
Fluid/Blood Leak 48 48
Crack 48 48
Separation Problem 46 46
Labelling, Instructions for Use or Training Problem 44 44
Unintended Deflation 44 44
Mechanical Problem 30 30
Defective Device 27 27
Patient-Device Incompatibility 26 26
Human-Device Interface Problem 23 23
Component Missing 21 21
Adverse Event Without Identified Device or Use Problem 20 20
Decrease in Pressure 20 20
Physical Resistance/Sticking 18 18
Fracture 18 18
Burst Container or Vessel 16 16
Delivered as Unsterile Product 16 16
Inadequacy of Device Shape and/or Size 16 16
Component Incompatible 16 16
Material Fragmentation 15 15
Partial Blockage 15 15
Malposition of Device 15 15
Tear, Rip or Hole in Device Packaging 13 13
Difficult to Remove 12 12
Gel Leak 12 12
Fitting Problem 12 12
Material Too Rigid or Stiff 12 12
Unsealed Device Packaging 11 11
Peeled/Delaminated 11 11
Device Damaged Prior to Use 11 11
Device Dislodged or Dislocated 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Difficult to Insert 9 9
Failure to Deflate 9 9
Complete Blockage 9 9
Patient Device Interaction Problem 9 9
Suction Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Structural Problem 8 8
Off-Label Use 8 8
Nonstandard Device 8 8
Device Misassembled During Manufacturing /Shipping 7 7
Tidal Volume Fluctuations 7 7
Migration or Expulsion of Device 7 7
Product Quality Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Separation Failure 6 6
Improper Flow or Infusion 6 6
Output Problem 6 6
Material Too Soft/Flexible 5 5
Device Contaminated During Manufacture or Shipping 5 5
Infusion or Flow Problem 5 5
Illegible Information 4 4
False Alarm 4 4
Missing Information 4 4
Contamination 4 4
Loss of or Failure to Bond 4 4
Ventilation Problem in Device Environment 4 4
Mechanical Jam 4 4
Blocked Connection 4 4
Device Alarm System 4 4
Failure to Disconnect 4 4
Entrapment of Device 4 4
Insufficient Flow or Under Infusion 3 3
Difficult to Advance 3 3
Collapse 3 3
Material Perforation 3 3
Device Slipped 3 3
Installation-Related Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Dent in Material 3 3
Increase in Pressure 3 3
No Apparent Adverse Event 3 3
Unintended Ejection 3 3
Material Invagination 3 3
No Flow 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2282 2282
Unintended Extubation 1070 1070
Extubate 692 692
No Consequences Or Impact To Patient 648 648
Insufficient Information 599 599
No Patient Involvement 504 504
No Known Impact Or Consequence To Patient 283 283
Low Oxygen Saturation 214 214
No Information 176 176
Hypoxia 55 55
Unspecified Tissue Injury 50 50
Hypoventilation 49 49
Airway Obstruction 39 39
Cardiac Arrest 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Decreased Respiratory Rate 28 28
Death 28 28
Respiratory Insufficiency 27 27
Hemorrhage/Bleeding 24 24
Injury 20 20
Pneumothorax 19 19
Respiratory Failure 15 15
Respiratory Arrest 15 15
Bradycardia 14 14
No Code Available 14 14
Dyspnea 13 13
Swelling/ Edema 13 13
Bronchospasm 12 12
Unspecified Respiratory Problem 12 12
Respiratory Distress 10 10
Foreign Body In Patient 10 10
Obstruction/Occlusion 10 10
Aspiration/Inhalation 9 9
Pain 8 8
Increased Respiratory Rate 7 7
Tissue Damage 7 7
Swelling 6 6
Pulmonary Emphysema 6 6
Granuloma 6 6
Device Embedded In Tissue or Plaque 5 5
Pneumonia 5 5
Patient Problem/Medical Problem 5 5
Low Blood Pressure/ Hypotension 5 5
Discomfort 4 4
Wheezing 4 4
Adult Respiratory Distress Syndrome 4 4
Reaction 4 4
Ventilator Dependent 4 4
Tachycardia 4 4
Forced Expiratory Volume Increased 3 3
Laceration(s) 3 3
Ulcer 3 3
Post Traumatic Wound Infection 3 3
Bronchitis 3 3
Apnea 3 3
Edema 2 2
Skin Inflammation/ Irritation 2 2
Necrosis 2 2
Pulmonary Edema 2 2
Anaphylactoid 2 2
Respiratory Acidosis 2 2
Fluid Discharge 2 2
Distress 2 2
Vomiting 2 2
Unspecified Infection 2 2
Dysphagia/ Odynophagia 2 2
Erythema 2 2
Anxiety 2 2
Complaint, Ill-Defined 2 2
Unintended Radiation Exposure 2 2
Asystole 2 2
Localized Skin Lesion 2 2
Abnormal Blood Gases 1 1
Arrhythmia 1 1
Cardiac Enzyme Elevation 1 1
Cellulitis 1 1
Convulsion/Seizure 1 1
Abrasion 1 1
Cyanosis 1 1
Intracranial Hemorrhage 1 1
Inflammation 1 1
Ischemia Stroke 1 1
Pleural Effusion 1 1
Sore Throat 1 1
Respiratory Distress Syndrome of Newborns 1 1
Burning Sensation 1 1
Test Result 1 1
Failure of Implant 1 1
Coma 1 1
Therapeutic Effects, Unexpected 1 1
Perforation 1 1
Abscess 1 1
Skin Irritation 1 1
Cardiopulmonary Arrest 1 1
High Blood Pressure/ Hypertension 1 1
Multiple Fractures 1 1
Blood Loss 1 1
Chest Pain 1 1
Stacking Breaths 1 1
Forced Expiratory Volume Decreased 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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