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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, tracheal/bronchial, differential ventilation (w/wo connector)
Product CodeCBI
Regulation Number 868.5740
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
HYTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K232529  Disposable Double Lumen Endobronchial Tube
  2.  K232580  Disposable Endobronchial Blocker Tube

MDR Year MDR Reports MDR Events
2019 94 94
2020 87 87
2021 159 159
2022 127 127
2023 94 94
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 200 200
Gas/Air Leak 69 69
Inflation Problem 63 63
Leak/Splash 54 54
Deflation Problem 17 17
Fracture 13 13
Mechanical Problem 13 13
Crack 11 11
Component Missing 11 11
Material Deformation 11 11
Material Separation 8 8
Material Rupture 7 7
Use of Device Problem 7 7
Infusion or Flow Problem 7 7
Ejection Problem 7 7
Material Split, Cut or Torn 6 6
Material Twisted/Bent 6 6
Separation Failure 6 6
Material Puncture/Hole 6 6
Incomplete or Missing Packaging 5 5
Obstruction of Flow 5 5
Unsealed Device Packaging 5 5
Output Problem 5 5
Failure to Deflate 4 4
Contamination /Decontamination Problem 4 4
Disconnection 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Failure to Unfold or Unwrap 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device Contaminated During Manufacture or Shipping 3 3
Unintended Deflation 3 3
Material Too Soft/Flexible 3 3
Packaging Problem 3 3
Incomplete or Inadequate Connection 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Deformation Due to Compressive Stress 2 2
Defective Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Fitting Problem 2 2
Fluid/Blood Leak 2 2
Complete Blockage 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 1 1
Decrease in Pressure 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Material Perforation 1 1
Failure to Disconnect 1 1
Solder Joint Fracture 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Blocked Connection 1 1
Connection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
No Flow 1 1
Activation Problem 1 1
Separation Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 351 351
No Consequences Or Impact To Patient 74 74
Insufficient Information 46 46
No Patient Involvement 45 45
No Known Impact Or Consequence To Patient 29 29
Low Oxygen Saturation 11 11
Extubate 11 11
No Information 9 9
Respiratory Failure 8 8
Hypoxia 7 7
Ventilator Dependent 4 4
Decreased Respiratory Rate 4 4
Pain 3 3
Obstruction/Occlusion 2 2
Exsanguination 2 2
Pulmonary Embolism 2 2
Airway Obstruction 2 2
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Unintended Extubation 2 2
Device Embedded In Tissue or Plaque 1 1
Respiratory Insufficiency 1 1
Unspecified Kidney or Urinary Problem 1 1
Foreign Body In Patient 1 1
Bradycardia 1 1
Chest Pain 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
Decreased Peak Expiratory Flow rate 1 1
Pneumothorax 1 1
Sepsis 1 1
Septic Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Jul-20-2022
2 Teleflex Medical II Dec-18-2019
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