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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
Product CodeCAT
Regulation Number 868.5340
Device Class 1

MDR Year MDR Reports MDR Events
2019 105 105
2020 135 135
2021 128 128
2022 74 74
2023 133 133
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Break 228 228
Detachment of Device or Device Component 135 135
Material Split, Cut or Torn 87 87
Device Handling Problem 65 65
Disconnection 37 37
Use of Device Problem 24 24
Material Integrity Problem 18 18
Material Separation 15 15
Gas/Air Leak 13 13
Adverse Event Without Identified Device or Use Problem 9 9
Leak/Splash 9 9
Connection Problem 8 8
Patient Device Interaction Problem 8 8
Obstruction of Flow 8 8
Patient-Device Incompatibility 7 7
Appropriate Term/Code Not Available 7 7
Material Deformation 6 6
Material Twisted/Bent 6 6
Loss of or Failure to Bond 6 6
Material Puncture/Hole 5 5
Loose or Intermittent Connection 4 4
Crack 4 4
Degraded 4 4
No Flow 4 4
Insufficient Information 4 4
Deformation Due to Compressive Stress 4 4
Contamination /Decontamination Problem 3 3
Device Dislodged or Dislocated 3 3
Unintended Movement 3 3
No Apparent Adverse Event 3 3
Contamination 3 3
Inflation Problem 3 3
Material Too Rigid or Stiff 3 3
Device Slipped 3 3
Stretched 2 2
Failure to Unfold or Unwrap 2 2
Device Emits Odor 2 2
Burst Container or Vessel 2 2
Complete Blockage 2 2
Fluid/Blood Leak 2 2
Material Too Soft/Flexible 2 2
Pressure Problem 2 2
Defective Device 2 2
Defective Component 2 2
Inaccurate Delivery 1 1
Blocked Connection 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Fracture 1 1
Material Fragmentation 1 1
Gas Output Problem 1 1
Material Disintegration 1 1
Fire 1 1
Inaccurate Flow Rate 1 1
Partial Blockage 1 1
Decoupling 1 1
Device Appears to Trigger Rejection 1 1
Inadequacy of Device Shape and/or Size 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Device Damaged Prior to Use 1 1
Sharp Edges 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 305 305
No Known Impact Or Consequence To Patient 98 98
Low Oxygen Saturation 56 56
No Consequences Or Impact To Patient 48 48
Insufficient Information 19 19
No Patient Involvement 14 14
Pressure Sores 10 10
Hypoxia 9 9
Skin Inflammation/ Irritation 8 8
Hypersensitivity/Allergic reaction 6 6
Rash 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Information 3 3
Unspecified Respiratory Problem 3 3
Respiratory Distress 3 3
Tissue Breakdown 3 3
Superficial (First Degree) Burn 3 3
Pain 3 3
Fall 3 3
Burn(s) 3 3
Death 3 3
Bradycardia 2 2
Bruise/Contusion 2 2
Skin Irritation 2 2
Burning Sensation 2 2
Sinus Perforation 2 2
Decreased Respiratory Rate 2 2
Swelling/ Edema 2 2
Unspecified Tissue Injury 1 1
Cough 1 1
Epistaxis 1 1
Respiratory Acidosis 1 1
Partial thickness (Second Degree) Burn 1 1
Swelling 1 1
Vomiting 1 1
Patient Problem/Medical Problem 1 1
Discomfort 1 1
Injury 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Syncope 1 1
Apnea 1 1
Dyspnea 1 1
Chest Pain 1 1
Cyanosis 1 1
Bone Fracture(s) 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Edema 1 1
Laceration(s) 1 1

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