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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
ETVIEW LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
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
2017 812 812
2018 973 973
2019 1379 1379
2020 1071 1071
2021 1326 1326
2022 595 595

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Leak 1262 1262
Inflation Problem 956 956
Use of Device Problem 897 897
Leak/Splash 460 460
Defective Component 314 314
Disconnection 284 284
Material Split, Cut or Torn 198 198
Detachment of Device or Device Component 197 197
Connection Problem 144 144
Air Leak 139 139
Deflation Problem 131 131
Break 96 96
Material Separation 87 87
Material Puncture/Hole 76 76
Loose or Intermittent Connection 74 74
Material Deformation 74 74
Material Integrity Problem 69 69
Obstruction of Flow 66 66
Material Rupture 63 63
Device Markings/Labelling Problem 61 61
Insufficient Information 61 61
Pressure Problem 58 58
Appropriate Term/Code Not Available 55 55
Crack 52 52
Contamination /Decontamination Problem 50 50
Deformation Due to Compressive Stress 43 43
Human-Device Interface Problem 43 43
Material Twisted/Bent 40 40
Device Operates Differently Than Expected 39 39
Fluid Leak 38 38
Partial Blockage 33 33
Contamination 32 32
Mechanical Problem 26 26
Detachment Of Device Component 25 25
Defective Device 25 25
Contamination of Device Ingredient or Reagent 25 25
Component Missing 24 24
Inadequacy of Device Shape and/or Size 24 24
Labelling, Instructions for Use or Training Problem 23 23
Decrease in Pressure 23 23
Burst Container or Vessel 23 23
Inadequate Instructions for Healthcare Professional 22 22
Adverse Event Without Identified Device or Use Problem 22 22
Kinked 20 20
Fracture 17 17
Malposition of Device 16 16
Hole In Material 15 15
Device Damaged Prior to Use 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Material Too Rigid or Stiff 13 13
Material Fragmentation 13 13
Material Discolored 12 12
Device Dislodged or Dislocated 12 12
Packaging Problem 12 12
Patient-Device Incompatibility 11 11
Peeled/Delaminated 11 11
Occlusion Within Device 10 10
Suction Problem 10 10
Gel Leak 10 10
Device Alarm System 10 10
Unintended Deflation 10 10
Tear, Rip or Hole in Device Packaging 9 9
Device Contamination with Chemical or Other Material 8 8
Complete Blockage 8 8
Product Quality Problem 8 8
Ejection Problem 8 8
Physical Resistance/Sticking 8 8
Patient Device Interaction Problem 7 7
Migration or Expulsion of Device 7 7
Bent 7 7
Output Problem 7 7
Therapeutic or Diagnostic Output Failure 6 6
Torn Material 6 6
Fitting Problem 6 6
Material Perforation 6 6
Separation Failure 6 6
Component Incompatible 6 6
Collapse 6 6
Difficult to Insert 6 6
Difficult to Remove 6 6
Tidal Volume Fluctuations 6 6
Separation Problem 6 6
Off-Label Use 5 5
Unintended Movement 5 5
No Flow 5 5
Device Contaminated During Manufacture or Shipping 5 5
Improper Flow or Infusion 4 4
Split 4 4
Device Emits Odor 4 4
Unsealed Device Packaging 4 4
False Alarm 4 4
Material Too Soft/Flexible 4 4
Failure to Deflate 4 4
Illegible Information 3 3
Loss of or Failure to Bond 3 3
Unintended Ejection 3 3
Increase in Pressure 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Dent in Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1124 1124
No Consequences Or Impact To Patient 1083 1083
Extubate 1056 1056
No Patient Involvement 895 895
No Known Impact Or Consequence To Patient 738 738
Unintended Extubation 611 611
No Information 298 298
Insufficient Information 282 282
Low Oxygen Saturation 168 168
Hypoxia 53 53
Death 47 47
No Code Available 37 37
Unspecified Tissue Injury 32 32
Airway Obstruction 26 26
Injury 24 24
Cardiac Arrest 20 20
Pneumothorax 19 19
Respiratory Distress 19 19
Bradycardia 13 13
Respiratory Failure 13 13
Hypoventilation 12 12
Patient Problem/Medical Problem 12 12
Bronchospasm 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Hemorrhage/Bleeding 11 11
Aspiration/Inhalation 10 10
Dyspnea 9 9
Obstruction/Occlusion 9 9
Tissue Damage 8 8
Swelling 7 7
Unspecified Respiratory Problem 7 7
Respiratory Insufficiency 7 7
Device Embedded In Tissue or Plaque 6 6
Blood Loss 6 6
Pulmonary Emphysema 6 6
Granuloma 6 6
Low Blood Pressure/ Hypotension 5 5
Vomiting 5 5
Ventilator Dependent 5 5
Foreign Body In Patient 5 5
Respiratory Arrest 5 5
Swelling/ Edema 5 5
Reaction 4 4
Decreased Respiratory Rate 4 4
Tachycardia 4 4
Adult Respiratory Distress Syndrome 4 4
Pain 3 3
Laceration(s) 3 3
Edema 3 3
Bronchitis 3 3
Sedation 3 3
Increased Respiratory Rate 3 3
Forced Expiratory Volume Increased 3 3
Post Traumatic Wound Infection 3 3
Fluid Discharge 3 3
Unintended Radiation Exposure 2 2
Localized Skin Lesion 2 2
Respiratory Acidosis 2 2
Pneumonia 2 2
Complaint, Ill-Defined 2 2
Anaphylactoid 2 2
Skin Erosion 2 2
Skin Irritation 2 2
Atrial Fibrillation 2 2
Apnea 2 2
Cardiopulmonary Arrest 2 2
Necrosis 2 2
Unspecified Infection 2 2
Encephalopathy 2 2
Bone Fracture(s) 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Occlusion 1 1
Paralysis 1 1
Perforation 1 1
Respiratory Distress Syndrome of Newborns 1 1
Cellulitis 1 1
Chest Pain 1 1
Cyanosis 1 1
Dysphagia/ Odynophagia 1 1
Abnormal Blood Gases 1 1
Stacking Breaths 1 1
Abscess 1 1
Suffocation 1 1
Therapeutic Effects, Unexpected 1 1
Burning Sensation 1 1
Rupture 1 1
Brain Injury 1 1
Ulcer 1 1
Anxiety 1 1
Distress 1 1
Discomfort 1 1
Choking 1 1
Loss Of Pulse 1 1
Coma 1 1
Loss of consciousness 1 1
Sore Throat 1 1
Sensitivity of Teeth 1 1
Tooth Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation I Jul-30-2019
2 Flexicare Medical Ltd. I Nov-26-2020
3 Smiths Medical ASD Inc. II Oct-27-2021
4 TELEFLEX MEDICAL INC II Jul-10-2020
5 Teleflex Medical I Sep-09-2019
6 Teleflex Medical I Jun-19-2019
7 Teleflex Medical II May-29-2019
8 Teleflex Medical II Feb-09-2017
9 Teleflex Medical Europe Ltd II Aug-19-2021
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