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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
2018 39 39
2019 62 62
2020 71 71
2021 138 138
2022 244 244
2023 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 131 131
Gas/Air Leak 122 122
Material Puncture/Hole 25 25
Loose or Intermittent Connection 22 22
Crack 21 21
Defective Component 21 21
Material Deformation 18 18
Disconnection 18 18
Detachment of Device or Device Component 17 17
Fitting Problem 16 16
Connection Problem 15 15
Break 13 13
Material Integrity Problem 12 12
Component Missing 10 10
Contamination /Decontamination Problem 9 9
Inflation Problem 9 9
Material Split, Cut or Torn 9 9
Tear, Rip or Hole in Device Packaging 7 7
Obstruction of Flow 7 7
Fluid/Blood Leak 6 6
Fracture 5 5
Gas Output Problem 5 5
Device Damaged Prior to Use 5 5
Insufficient Information 5 5
Pressure Problem 4 4
Device Slipped 4 4
Material Twisted/Bent 4 4
Product Quality Problem 4 4
Delivered as Unsterile Product 3 3
Shipping Damage or Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Misconnection 3 3
Material Fragmentation 3 3
Device Operates Differently Than Expected 3 3
Incomplete or Missing Packaging 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Appropriate Term/Code Not Available 3 3
Separation Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Air/Gas in Device 3 3
Unintended Deflation 2 2
Physical Resistance/Sticking 2 2
No Flow 2 2
No Pressure 2 2
Blocked Connection 2 2
Failure to Deliver 2 2
Microbial Contamination of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Loss of or Failure to Bond 2 2
Material Perforation 2 2
Free or Unrestricted Flow 2 2
Infusion or Flow Problem 2 2
Complete Blockage 2 2
Device Alarm System 2 2
Deflation Problem 2 2
Material Discolored 2 2
Mechanical Problem 2 2
Occlusion Within Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Too Rigid or Stiff 2 2
Material Separation 1 1
Decrease in Pressure 1 1
Melted 1 1
Moisture Damage 1 1
Difficult to Insert 1 1
Decoupling 1 1
Defective Alarm 1 1
Partial Blockage 1 1
Hole In Material 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Improper Flow or Infusion 1 1
Compatibility Problem 1 1
Moisture or Humidity Problem 1 1
Difficult to Open or Close 1 1
Failure of Device to Self-Test 1 1
Device Markings/Labelling Problem 1 1
Failure to Disconnect 1 1
Insufficient Flow or Under Infusion 1 1
Tidal Volume Fluctuations 1 1
Use of Device Problem 1 1
Deformation Due to Compressive Stress 1 1
Packaging Problem 1 1
Power Problem 1 1
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Premature Separation 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 356 356
No Patient Involvement 73 73
No Consequences Or Impact To Patient 50 50
No Known Impact Or Consequence To Patient 33 33
Insufficient Information 23 23
Low Oxygen Saturation 7 7
Hypoxia 7 7
Respiratory Distress 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Information 4 4
Foreign Body In Patient 2 2
Decreased Respiratory Rate 2 2
Hypoventilation 2 2
Viral Infection 2 2
Bacterial Infection 2 2
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Death 1 1
Dyspnea 1 1
Pain 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Extubate 1 1
Irritability 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Respiratory Failure 1 1
Test Result 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Balance Problems 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intersurgical Inc II Jun-27-2018
2 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
3 Medline Industries Inc II Dec-18-2019
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