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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
Regulation Description Tracheal tube fixation device.
Product CodeCBH
Regulation Number 868.5770
Device Class 1

MDR Year MDR Reports MDR Events
2020 67 67
2021 27 27
2022 47 47
2023 22 23
2024 20 20
2025 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 43 43
Break 32 32
Material Separation 27 27
Loss of or Failure to Bond 19 19
Patient Device Interaction Problem 13 13
Fracture 11 11
Detachment of Device or Device Component 9 9
Insufficient Information 9 9
Appropriate Term/Code Not Available 7 7
Device Dislodged or Dislocated 7 7
Use of Device Problem 7 7
Separation Problem 5 5
Device Slipped 4 5
Material Split, Cut or Torn 3 3
Device-Device Incompatibility 3 3
Difficult to Open or Close 3 3
Disconnection 3 3
Material Integrity Problem 2 2
Positioning Problem 2 2
Gas/Air Leak 2 3
Sharp Edges 2 2
Material Deformation 2 2
Pressure Problem 2 2
Material Frayed 2 2
Loose or Intermittent Connection 2 2
Improper or Incorrect Procedure or Method 2 2
Physical Resistance/Sticking 1 1
Material Disintegration 1 1
Malposition of Device 1 1
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Remove 1 1
Mechanical Problem 1 1
Material Fragmentation 1 1
Stretched 1 1
Material Too Rigid or Stiff 1 1
Entrapment of Device 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Inflation Problem 1 1
No Apparent Adverse Event 1 1
Migration 1 1
Nonstandard Device 1 1
Inadequate or Insufficient Training 1 1
Connection Problem 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
Insufficient Information 31 32
No Consequences Or Impact To Patient 28 28
Pressure Sores 25 25
Tissue Breakdown 18 18
Hypoventilation 15 15
Unspecified Tissue Injury 13 13
Extubate 9 9
No Known Impact Or Consequence To Patient 8 8
Skin Tears 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cardiac Arrest 4 4
Skin Erosion 4 4
Unintended Extubation 3 3
Airway Obstruction 3 3
Low Oxygen Saturation 3 3
Ulcer 3 3
Erythema 3 3
Foreign Body In Patient 3 3
Rash 2 2
Laceration(s) 2 2
Cough 2 2
Injury 2 2
Unspecified Respiratory Problem 2 2
Skin Discoloration 2 2
Pleural Effusion 1 1
Fall 1 1
Choking 1 1
Fluid Discharge 1 1
Bradycardia 1 1
Hypoxia 1 1
Hyperventilation 1 1
Atrial Fibrillation 1 1
Inflammation 1 1
Skin Inflammation/ Irritation 1 1
Respiratory Insufficiency 1 1
Hemorrhage/Bleeding 1 1
Respiratory Distress 1 1
Respiratory Arrest 1 1
No Code Available 1 1
Unspecified Infection 1 1
Respiratory Failure 1 1
Device Embedded In Tissue or Plaque 1 1
Aspiration Pneumonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hollister Incorporated II Feb-19-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Dec-18-2024
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