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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)
Regulation Description Tracheal/bronchial differential ventilation tube.
Product CodeCBI
Regulation Number 868.5740
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETVIEW LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 8 8
2016 29 29
2017 61 61
2018 65 65
2019 94 94
2020 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 58 58
Inflation Problem 48 48
Break 46 46
Cuff 16 16
Crack 13 13
Output Problem 13 13
Cap 10 10
Tube 9 9
Gas Leak 9 9
Device Operates Differently Than Expected 8 8
Material Twisted/Bent 8 8
Air Leak 8 8
Deflation Problem 8 8
Material Separation 8 8
Material Deformation 8 8
Mechanical Problem 7 7
Ejection Problem 7 7
Hole In Material 6 6
Connection Problem 6 6
Fitting Problem 5 5
Disconnection 4 4
Device Markings/Labelling Problem 4 4
Suction Problem 4 4
Material Split, Cut or Torn 4 4
Device Dislodged or Dislocated 4 4
Infusion or Flow Problem 4 4
System 3 3
Fracture 3 3
Kinked 3 3
Device Alarm System 3 3
Port 3 3
Decrease in Pressure 3 3
Material Rupture 2 2
Inadequacy of Device Shape and/or Size 2 2
Loose or Intermittent Connection 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Complete Blockage 2 2
Component Missing 2 2
Material Too Rigid or Stiff 2 2
Packaging Problem 2 2
Obstruction of Flow 2 2
Separation Failure 1 1
Physical Resistance 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Component or Accessory Incompatibility 1 1
Detachment of Device or Device Component 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Device Issue 1 1
Failure to Unfold or Unwrap 1 1
Difficult To Position 1 1
Material Puncture/Hole 1 1
Labelling, Instructions for Use or Training Problem 1 1
Burst Container or Vessel 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Incomplete or Inadequate Connection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Delivered as Unsterile Product 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Balloon 1 1
Label 1 1
Partial Blockage 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 123 123
No Known Impact Or Consequence To Patient 99 99
No Patient Involvement 53 53
Extubate 21 21
Respiratory Failure 8 8
Hypoxia 7 7
No Information 6 6
Low Oxygen Saturation 5 5
No Code Available 3 3
Pneumothorax 2 2
Shock 2 2
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 2 2
Device Embedded In Tissue or Plaque 2 2
Death 2 2
Edema 1 1
Hemorrhage/Bleeding 1 1
Bleeding 1 1
Chest Pain 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Parker Medical II Mar-03-2017
2 Teleflex Medical II Dec-18-2019
3 Teleflex Medical I Aug-20-2015
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