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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 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 312 312
Air Leak 239 239
Gas/Air Leak 229 229
Inflation Problem 217 217
Break 169 169
Detachment of Device or Device Component 115 115
Crack 82 82
Fracture 70 70
Connection Problem 62 62
Defective Component 57 57
Disconnection 57 57
Material Separation 51 51
Component Missing 48 48
Contamination /Decontamination Problem 47 47
Fluid/Blood Leak 42 42
Material Split, Cut or Torn 40 40
Material Puncture/Hole 38 38
Deflation Problem 36 36
Device Markings/Labelling Problem 33 33
Separation Problem 31 31
Decrease in Pressure 30 30
Defective Device 29 29
Detachment Of Device Component 27 27
Obstruction of Flow 26 26
Material Deformation 26 26
Material Integrity Problem 25 25
Use of Device Problem 25 25
Unintended Deflation 24 24
Device Damaged Prior to Use 23 23
Incomplete or Missing Packaging 22 22
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
Difficult to Insert 14 14
Material Discolored 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
Fitting Problem 8 8
Material Perforation 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 6 6
Complete Blockage 6 6
Component(s), broken 6 6
Sticking 6 6
No Pressure 6 6
Expiration Date Error 6 6
Split 6 6
Problem with Sterilization 5 5
Improper or Incorrect Procedure or Method 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
Packaging Problem 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
Patient-Device Incompatibility 4 4
Contamination of Device Ingredient or Reagent 4 4
Failure to Disconnect 4 4
Separation Failure 4 4
Structural Problem 4 4
Malposition of Device 4 4
Cut In Material 3 3
Tidal Volume Fluctuations 3 3
Insufficient Flow or Under Infusion 3 3
Failure to Deliver 3 3
Migration or Expulsion of Device 3 3
Misassembled 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1166 1166
No Consequences Or Impact To Patient 579 579
Insufficient Information 202 202
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
Respiratory Distress 16 16
No Code Available 16 16
Dyspnea 15 15
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
Aspiration Pneumonitis 6 6
Device Embedded In Tissue or Plaque 6 6
Cardiac Arrest 6 6
Aspiration/Inhalation 6 6
Hypoventilation 6 6
Pain 5 5
Ventilator Dependent 5 5
Respiratory Insufficiency 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 4 4
Blood Loss 4 4
Respiratory Failure 4 4
Pressure Sores 4 4
Distress 3 3
Tissue Damage 3 3
Irritation 3 3
Pneumonia 3 3
Injury 3 3
Fistula 3 3
Unspecified Infection 3 3
Abrasion 3 3
Cyanosis 3 3
Abnormal Blood Gases 2 2
Apnea 2 2
Failure of Implant 2 2
Granuloma 2 2
Pulmonary Emphysema 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
Ulcer 2 2
Swelling/ Edema 2 2
Blister 2 2
Skin Inflammation/ Irritation 1 1
Respiratory Arrest 1 1
Hematemesis 1 1
Salivary Hypersecretion 1 1
Stomatitis 1 1
Urethral Stenosis/Stricture 1 1
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
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
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
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

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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