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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
Insufficient Information 7 7
Detachment of Device or Device Component 7 7
Separation Problem 5 5
No Apparent Adverse Event 4 4
Use of Device Problem 4 4
Device Slipped 4 4
Material Split, Cut or Torn 4 4
Component Missing 3 3
Appropriate Term/Code Not Available 3 3
Difficult to Open or Close 3 3
Material Integrity Problem 2 2
Positioning Problem 2 2
Disconnection 2 2
Gas/Air Leak 2 2
Sharp Edges 2 2
Material Frayed 2 2
Material Deformation 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 1 1
Mechanical Problem 1 1
Malposition of Device 1 1
Entrapment of Device 1 1
Incomplete or Missing Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Material Too Rigid or Stiff 1 1
Inflation Problem 1 1
Migration 1 1
Material Fragmentation 1 1
Inadequate or Insufficient Training 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Stretched 1 1
Material Disintegration 1 1
Device Fell 1 1
Premature Separation 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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