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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
2014 145 145
2015 109 109
2016 174 174
2017 128 128
2018 91 91
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 279 279
Detachment of Device or Device Component 157 157
Device Handling Problem 123 123
Material Split, Cut or Torn 96 96
Disconnection 88 88
Device Issue 87 87
Detachment Of Device Component 43 43
Split 41 41
Kinked 39 39
Leak/Splash 38 38
Material Separation 37 37
Hole In Material 36 36
Use of Device Problem 34 34
Material Integrity Problem 27 27
Adverse Event Without Identified Device or Use Problem 23 23
Connection Problem 16 16
Device Operates Differently Than Expected 16 16
Gas/Air Leak 15 15
Improper or Incorrect Procedure or Method 15 15
Patient-Device Incompatibility 14 14
Torn Material 14 14
Improper Flow or Infusion 14 14
Folded 12 12
No Flow 11 11
Insufficient Information 11 11
Device Sensing Problem 10 10
Patient Device Interaction Problem 9 9
Obstruction of Flow 9 9
Loose or Intermittent Connection 8 8
Bent 8 8
Appropriate Term/Code Not Available 8 8
Material Deformation 8 8
Material Twisted/Bent 7 7
Device Contamination with Chemical or Other Material 7 7
Defective Device 7 7
Device Damaged Prior to Use 6 6
Loss of or Failure to Bond 6 6
Complete Blockage 6 6
Crack 6 6
Device Dislodged or Dislocated 6 6
Material Puncture/Hole 5 5
Unraveled Material 4 4
Degraded 4 4
Misassembled 4 4
Device Emits Odor 4 4
Deformation Due to Compressive Stress 4 4
No Apparent Adverse Event 4 4
Noise, Audible 3 3
Contamination /Decontamination Problem 3 3
Extrusion 3 3
Infusion or Flow Problem 3 3
Material Protrusion/Extrusion 3 3
Unintended Movement 3 3
Pressure Problem 3 3
Knotted 3 3
Inflation Problem 3 3
Fire 3 3
Contamination 3 3
Partial Blockage 3 3
Failure To Adhere Or Bond 3 3
Device Displays Incorrect Message 3 3
Malposition of Device 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 3 3
Material Too Rigid or Stiff 3 3
Stretched 2 2
Peeled/Delaminated 2 2
Blocked Connection 2 2
Failure to Unfold or Unwrap 2 2
Defective Component 2 2
Failure to Deliver 2 2
Air Leak 2 2
Burst Container or Vessel 2 2
Inaccurate Flow Rate 2 2
Fluid/Blood Leak 2 2
Fracture 2 2
Material Opacification 2 2
Occlusion Within Device 2 2
Physical Property Issue 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Human-Device Interface Problem 2 2
Material Too Soft/Flexible 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sharp Edges 1 1
Unexpected Shutdown 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Mechanical Jam 1 1
Medical Gas Supply Problem 1 1
Positioning Problem 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Unintended Collision 1 1
Material Fragmentation 1 1
Gas Output Problem 1 1
Restricted Flow rate 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 319 319
No Clinical Signs, Symptoms or Conditions 305 305
No Known Impact Or Consequence To Patient 262 262
Low Oxygen Saturation 142 142
No Patient Involvement 61 61
Respiratory Distress 36 36
Pressure Sores 21 21
Insufficient Information 19 19
No Information 14 14
Injury 13 13
Death 12 12
Hypoxia 11 11
Skin Inflammation/ Irritation 8 8
Pain 7 7
Fall 7 7
Hypersensitivity/Allergic reaction 6 6
Burn(s) 6 6
Rash 6 6
No Code Available 6 6
Skin Irritation 5 5
Dyspnea 5 5
Tissue Breakdown 5 5
Superficial (First Degree) Burn 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Respiratory Problem 3 3
High Oxygen Saturation 3 3
Decreased Respiratory Rate 3 3
Increased Respiratory Rate 3 3
Reaction 3 3
Complaint, Ill-Defined 3 3
Erythema 3 3
Bradycardia 3 3
Bruise/Contusion 3 3
Hemorrhage/Bleeding 2 2
Headache 2 2
Swelling 2 2
Laceration(s) 2 2
Skin Erosion 2 2
Perforation 2 2
Sinus Perforation 2 2
Discomfort 2 2
Burning Sensation 2 2
Hip Fracture 2 2
Patient Problem/Medical Problem 2 2
Skin Tears 2 2
Swelling/ Edema 2 2
Partial thickness (Second Degree) Burn 2 2
Unspecified Tissue Injury 1 1
Cough 1 1
Epistaxis 1 1
Burn, Thermal 1 1
Lethargy 1 1
Hospitalization required 1 1
Ischemic Heart Disease 1 1
Sudden Cardiac Death 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sore Throat 1 1
Extubate 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Choking 1 1
Dizziness 1 1
Excessive Tear Production 1 1
Therapeutic Response, Decreased 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Irritation 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Tachycardia 1 1
Ulceration 1 1
Abnormal Vaginal Discharge 1 1
Vomiting 1 1
Hearing Impairment 1 1
Bone Fracture(s) 1 1
Syncope 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1
Cyanosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. III Oct-05-2018
2 Teleflex Medical II Jun-07-2017
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