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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, fixation, tracheal tube
Product CodeCBH
Regulation Number 868.5770
Device Class 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 67 67
2021 27 27
2022 47 47
2023 22 22
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 38 38
Adverse Event Without Identified Device or Use Problem 35 35
Material Separation 23 23
Device Dislodged or Dislocated 12 12
Fracture 10 10
Loss of or Failure to Bond 9 9
Detachment of Device or Device Component 7 7
Insufficient Information 7 7
Separation Problem 5 5
Material Split, Cut or Torn 4 4
Device Slipped 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 4 4
Appropriate Term/Code Not Available 3 3
Difficult to Open or Close 3 3
Component Missing 3 3
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Sharp Edges 2 2
Material Integrity Problem 2 2
Positioning Problem 2 2
Gas/Air Leak 2 2
Patient Device Interaction Problem 2 2
Disconnection 2 2
Material Frayed 2 2
Material Twisted/Bent 1 1
Material Too Rigid or Stiff 1 1
Stretched 1 1
Premature Separation 1 1
Material Fragmentation 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Disintegration 1 1
Device Fell 1 1
Entrapment of Device 1 1
Malposition of Device 1 1
Inflation Problem 1 1
Physical Resistance/Sticking 1 1
Migration 1 1
Mechanical Problem 1 1
Incomplete or Missing Packaging 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Inadequate or Insufficient Training 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Consequences Or Impact To Patient 35 35
Insufficient Information 24 24
No Known Impact Or Consequence To Patient 19 19
Extubate 16 16
Tissue Breakdown 13 13
Pressure Sores 13 13
Hypoventilation 12 12
Unspecified Tissue Injury 5 5
Skin Tears 5 5
Cardiac Arrest 4 4
Skin Erosion 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unintended Extubation 3 3
Not Applicable 2 2
Airway Obstruction 2 2
Skin Discoloration 2 2
Foreign Body In Patient 2 2
Injury 2 2
Laceration(s) 2 2
Ulcer 2 2
Unspecified Respiratory Problem 2 2
Hypoxia 2 2
Aspiration Pneumonitis 1 1
Device Embedded In Tissue or Plaque 1 1
Respiratory Failure 1 1
Low Oxygen Saturation 1 1
Respiratory Insufficiency 1 1
Bradycardia 1 1
Fluid Discharge 1 1
Choking 1 1
Fall 1 1
Pleural Effusion 1 1
Rash 1 1
Atrial Fibrillation 1 1
Inflammation 1 1
Skin Inflammation/ Irritation 1 1
Respiratory Distress 1 1
Respiratory Arrest 1 1
No Code Available 1 1
Unspecified Infection 1 1

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