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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 7 7

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
Loss of or Failure to Bond 9 9
Fracture 8 8
Detachment of Device or Device Component 7 7
Insufficient Information 7 7
Separation Problem 5 5
Material Split, Cut or Torn 4 4
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Device Slipped 4 4
Difficult to Open or Close 3 3
Component Missing 3 3
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 2 2
Sharp Edges 2 2
Improper or Incorrect Procedure or Method 2 2
Positioning Problem 2 2
Gas/Air Leak 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Loose or Intermittent Connection 2 2
Material Frayed 2 2
Disconnection 2 2
Material Disintegration 1 1
Entrapment of Device 1 1
Inflation Problem 1 1
Material Fragmentation 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Material Too Rigid or Stiff 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Material Twisted/Bent 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Incomplete or Missing Packaging 1 1
Malposition of Device 1 1
Connection Problem 1 1
Device Fell 1 1
Physical Resistance/Sticking 1 1
Migration 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
No Consequences Or Impact To Patient 35 35
Insufficient Information 23 23
No Known Impact Or Consequence To Patient 19 19
Extubate 16 16
Tissue Breakdown 13 13
Pressure Sores 12 12
Hypoventilation 12 12
Skin Tears 5 5
Unspecified Tissue Injury 5 5
Cardiac Arrest 4 4
Skin Erosion 4 4
Unintended Extubation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Respiratory Problem 2 2
Skin Discoloration 2 2
Ulcer 2 2
Laceration(s) 2 2
Airway Obstruction 2 2
Hypoxia 2 2
Foreign Body In Patient 2 2
Not Applicable 2 2
Injury 2 2
Fluid Discharge 1 1
Choking 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
No Code Available 1 1
Aspiration Pneumonitis 1 1
Respiratory Arrest 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Infection 1 1
Inflammation 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Fall 1 1
Pleural Effusion 1 1
Rash 1 1
Respiratory Distress 1 1
Skin Inflammation/ Irritation 1 1

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