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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, tracheostomy (w/wo connector)
Product CodeBTO
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
REGULATORY AND MARKETING SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ADS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
VITALTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 173 173
2015 171 171
2016 212 212
2017 125 125
2018 162 162
2019 87 87
2020 113 113
2021 198 198
2022 770 770
2023 402 402
2024 119 119

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 312 312
Gas/Air Leak 240 240
Air Leak 239 239
Inflation Problem 223 223
Break 169 169
Detachment of Device or Device Component 115 115
Crack 82 82
Fracture 77 77
Connection Problem 62 62
Defective Component 59 59
Disconnection 57 57
Material Separation 51 51
Component Missing 49 49
Contamination /Decontamination Problem 47 47
Fluid/Blood Leak 42 42
Material Split, Cut or Torn 42 42
Material Puncture/Hole 40 40
Deflation Problem 36 36
Device Markings/Labelling Problem 34 34
Decrease in Pressure 32 32
Separation Problem 31 31
Defective Device 29 29
Obstruction of Flow 27 27
Detachment Of Device Component 27 27
Material Deformation 26 26
Material Integrity Problem 25 25
Use of Device Problem 25 25
Unintended Deflation 25 25
Incomplete or Missing Packaging 23 23
Device Damaged Prior to Use 23 23
Inadequacy of Device Shape and/or Size 22 22
Accessory Incompatible 20 20
Human-Device Interface Problem 20 20
Loose or Intermittent Connection 19 19
Pressure Problem 18 18
Material Rupture 17 17
Suction Problem 17 17
Tear, Rip or Hole in Device Packaging 16 16
Insufficient Information 16 16
Mechanical Problem 15 15
Material Discolored 15 15
Difficult to Insert 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Device Operates Differently Than Expected 12 12
Difficult to Remove 12 12
Material Fragmentation 11 11
Gel Leak 11 11
Device Dislodged or Dislocated 11 11
Material Twisted/Bent 11 11
Moisture or Humidity Problem 10 10
Nonstandard Device 10 10
Patient Device Interaction Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Torn Material 10 10
Hole In Material 8 8
Material Perforation 8 8
Fitting Problem 8 8
Deformation Due to Compressive Stress 7 7
Degraded 7 7
Device Alarm System 7 7
Unintended Movement 7 7
Positioning Problem 7 7
Material Too Soft/Flexible 7 7
Noise, Audible 7 7
Physical Resistance/Sticking 7 7
Complete Blockage 6 6
Component(s), broken 6 6
Sticking 6 6
No Pressure 6 6
Expiration Date Error 6 6
Split 6 6
Improper or Incorrect Procedure or Method 5 5
Problem with Sterilization 5 5
Packaging Problem 5 5
Compatibility Problem 5 5
Product Quality Problem 5 5
Labelling, Instructions for Use or Training Problem 5 5
Burst Container or Vessel 5 5
Bent 5 5
Partial Blockage 5 5
Premature Separation 5 5
Appropriate Term/Code Not Available 4 4
Component Incompatible 4 4
Occlusion Within Device 4 4
Unsealed Device Packaging 4 4
Infusion or Flow Problem 4 4
Optical Discoloration 4 4
Difficult to Advance 4 4
Contamination of Device Ingredient or Reagent 4 4
Insufficient Flow or Under Infusion 4 4
Failure to Disconnect 4 4
Separation Failure 4 4
Structural Problem 4 4
Malposition of Device 4 4
Patient-Device Incompatibility 4 4
Cut In Material 3 3
Tidal Volume Fluctuations 3 3
Device Contamination with Body Fluid 3 3
Failure to Deliver 3 3
Migration or Expulsion of Device 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1194 1194
No Consequences Or Impact To Patient 579 579
Insufficient Information 209 209
No Known Impact Or Consequence To Patient 144 144
Extubate 81 81
No Information 58 59
Low Oxygen Saturation 43 43
Therapy/non-surgical treatment, additional 31 31
Decreased Respiratory Rate 29 29
No Patient Involvement 27 27
Airway Obstruction 24 24
Dyspnea 16 16
Respiratory Distress 16 16
No Code Available 16 16
Hemorrhage/Bleeding 13 13
Hypoxia 12 12
Death 12 12
Foreign Body In Patient 10 10
Discomfort 9 9
Pneumothorax 8 8
Bradycardia 8 8
Unintended Extubation 8 8
Respiratory Insufficiency 7 7
Hypoventilation 7 7
Cardiac Arrest 6 6
Aspiration/Inhalation 6 6
Aspiration Pneumonitis 6 6
Device Embedded In Tissue or Plaque 6 6
Pain 5 5
Ventilator Dependent 5 5
Respiratory Failure 4 4
Pressure Sores 4 4
Patient Problem/Medical Problem 4 4
Blood Loss 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Distress 3 3
Tissue Damage 3 3
Irritation 3 3
Pneumonia 3 3
Injury 3 3
Abrasion 3 3
Cyanosis 3 3
Fistula 3 3
Unspecified Infection 3 3
Failure of Implant 2 2
Granuloma 2 2
Pulmonary Emphysema 2 2
Abnormal Blood Gases 2 2
Apnea 2 2
Laceration(s) of Esophagus 2 2
Fever 2 2
Laceration(s) 2 2
Ventricular Fibrillation 2 2
Ventricular Tachycardia 2 2
Swelling 2 2
Brain Injury 2 2
Swelling/ Edema 2 2
Blister 2 2
Ulcer 2 2
Diminished Pulse Pressure 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Hospitalization required 1 1
Fluid Discharge 1 1
Myocardial Hypertrophy 1 1
Skin Inflammation/ Irritation 1 1
Respiratory Arrest 1 1
Hematemesis 1 1
Salivary Hypersecretion 1 1
Stomatitis 1 1
Urethral Stenosis/Stricture 1 1
Shock, Traumatic 1 1
Thrombosis 1 1
Perforation 1 1
Pulmonary Edema 1 1
Perforation of Esophagus 1 1
Sore Throat 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Forced Expiratory Volume Decreased 1 1
Skin Inflammation 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Nasal Obstruction 1 1
Bacterial Infection 1 1
Wound Dehiscence 1 1
Adult Respiratory Distress Syndrome 1 1
Bruise/Contusion 1 1
Chemosis 1 1
Chest Pain 1 1
Crushing Injury 1 1
Encephalopathy 1 1
Fatigue 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypovolemic Shock 1 1
Infiltration into Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Mar-24-2016
2 Arcadia Medical Corporation II May-21-2012
3 Arcadia Medical Corporation II Jun-24-2011
4 Bryan Medical Inc I Jul-08-2013
5 Cardinal Health 200, LLC I Feb-16-2024
6 Gf Health Products, Inc. II Nov-09-2009
7 Instrumentation Industries Inc II Nov-12-2015
8 Instrumentation Industries Inc II Sep-03-2009
9 Nellcor Puritan Bennett Inc. (dba Covidien Ltd) I May-06-2010
10 Smiths Medical ASD Inc. II Jun-04-2019
11 Smiths Medical ASD Inc. II Jun-07-2018
12 Smiths Medical ASD, Inc. I Jan-19-2012
13 VBM Medical Inc. II Jun-28-2011
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