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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, nasal, oxygen
Regulation Description Nasal oxygen cannula.
Product CodeCAT
Regulation Number 868.5340
Device Class 1

MDR Year MDR Reports MDR Events
2021 128 128
2022 74 74
2023 116 117
2024 75 75
2025 81 81
2026 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Break 166 166
Detachment of Device or Device Component 129 129
Material Split, Cut or Torn 57 57
Disconnection 24 24
Use of Device Problem 18 18
Connection Problem 17 17
Material Twisted/Bent 16 16
Loose or Intermittent Connection 13 13
Obstruction of Flow 13 13
Patient Device Interaction Problem 13 13
Gas/Air Leak 11 11
Material Integrity Problem 11 11
Appropriate Term/Code Not Available 9 9
Patient-Device Incompatibility 7 7
Insufficient Flow or Under Infusion 6 6
Material Separation 5 5
Defective Device 5 5
Insufficient Information 5 5
Material Too Soft/Flexible 4 4
Material Rupture 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Puncture/Hole 4 4
Crack 4 5
Incomplete or Inadequate Connection 4 4
Defective Component 3 3
Loss of or Failure to Bond 3 3
Contamination 3 3
Contamination /Decontamination Problem 3 3
Leak/Splash 3 3
Material Too Rigid or Stiff 3 3
Inflation Problem 3 3
Device Dislodged or Dislocated 3 3
Fire 2 2
Blocked Connection 2 2
Infusion or Flow Problem 2 2
Material Deformation 2 2
Partial Blockage 2 2
Device Emits Odor 2 2
Pressure Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Unfold or Unwrap 2 2
Noise, Audible 1 1
Temperature Problem 1 1
Fluid/Blood Leak 1 1
Failure to Disconnect 1 1
Fitting Problem 1 1
Chemical Problem 1 1
Suction Problem 1 1
Device Appears to Trigger Rejection 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 335 335
Low Oxygen Saturation 68 69
Insufficient Information 32 32
Hypoxia 9 9
Skin Inflammation/ Irritation 8 8
Pressure Sores 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Hypersensitivity/Allergic reaction 6 6
Rash 5 5
Epistaxis 4 4
Burn(s) 4 4
Unspecified Respiratory Problem 4 4
Fall 3 3
Partial thickness (Second Degree) Burn 3 3
Headache 3 3
Tissue Breakdown 3 3
Superficial (First Degree) Burn 2 2
Aspiration/Inhalation 2 2
Sinus Perforation 2 2
Discomfort 2 2
Swelling/ Edema 2 2
Decreased Respiratory Rate 2 2
Bruise/Contusion 2 2
Hearing Impairment 1 1
Hip Fracture 1 1
Inflammation 1 1
Obstruction/Occlusion 1 1
Skin Erosion 1 1
Burning Sensation 1 1
Chest Pain 1 1
Dyspnea 1 1
Laceration(s) 1 1
Pain 1 1
Fluid Discharge 1 1
Cough 1 1
Unspecified Tissue Injury 1 1
Caustic/Chemical Burns 1 1
Hemorrhage/Bleeding 1 1

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