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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device circuit, breathing (w connector, adaptor, y piece)
Product CodeCAI
Regulation Number 868.5240
Device Class 1

MDR Year MDR Reports MDR Events
2017 154 154
2018 39 39
2019 62 62
2020 71 71
2021 138 138
2022 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 129 129
Leak/Splash 105 105
Product Quality Problem 102 102
Gas Leak 97 97
Crack 26 26
Loose or Intermittent Connection 20 20
Connection Problem 16 16
Detachment of Device or Device Component 16 16
Fitting Problem 15 15
Defective Component 14 14
Material Integrity Problem 10 10
Material Puncture/Hole 9 9
Component Missing 9 9
Break 8 8
Fluid Leak 7 7
Fracture 7 7
Material Deformation 6 6
Material Split, Cut or Torn 6 6
Gas Output Problem 5 5
Air Leak 5 5
Occlusion Within Device 5 5
Contamination /Decontamination Problem 5 5
Device Displays Incorrect Message 4 4
Device Operates Differently Than Expected 4 4
Material Separation 4 4
Inflation Problem 4 4
Insufficient Information 4 4
Separation Problem 3 3
Air/Gas in Device 3 3
Misconnection 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Pressure Problem 3 3
Obstruction of Flow 3 3
Device Damaged Prior to Use 3 3
Microbial Contamination of Device 2 2
Material Perforation 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Deliver 2 2
Tear, Rip or Hole in Device Packaging 2 2
Blocked Connection 2 2
Defective Device 2 2
Material Twisted/Bent 2 2
No Flow 2 2
No Pressure 2 2
Infusion or Flow Problem 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Partial Blockage 2 2
Loss of or Failure to Bond 2 2
Hole In Material 2 2
Material Fragmentation 2 2
Unintended Deflation 2 2
Physical Resistance/Sticking 2 2
Noise, Audible 2 2
Appropriate Term/Code Not Available 1 1
Premature Separation 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Device Alarm System 1 1
Defective Alarm 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Decoupling 1 1
Deflation Problem 1 1
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Decrease in Pressure 1 1
Difficult to Remove 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Melted 1 1
Misassembled 1 1
Improper Flow or Infusion 1 1
Difficult to Open or Close 1 1
Device Markings/Labelling Problem 1 1
Packaging Problem 1 1
Power Problem 1 1
Moisture or Humidity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Deformation Due to Compressive Stress 1 1
Failure to Disconnect 1 1
Insufficient Flow or Under Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 210 210
No Known Impact Or Consequence To Patient 149 149
No Patient Involvement 83 83
No Consequences Or Impact To Patient 63 63
Insufficient Information 22 22
Low Oxygen Saturation 13 13
Hypoxia 10 10
Respiratory Distress 7 7
No Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hypoventilation 3 3
Foreign Body In Patient 2 2
Viral Infection 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Cardiopulmonary Arrest 1 1
Death 1 1
Pulmonary Edema 1 1
Awareness during Anaesthesia 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Extubate 1 1
Swelling 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intersurgical Inc II Jun-27-2018
2 Medline Industries Inc II Dec-18-2019
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