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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
2019 62 62
2020 71 71
2021 138 138
2022 244 244
2023 251 251
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 222 222
Leak/Splash 159 159
Material Puncture/Hole 44 44
Crack 32 32
Break 28 28
Loose or Intermittent Connection 25 25
Defective Component 23 23
Material Deformation 22 22
Component Missing 21 21
Fitting Problem 18 18
Detachment of Device or Device Component 17 17
Connection Problem 17 17
Obstruction of Flow 16 16
Disconnection 16 16
Failure to Deliver 15 15
Material Split, Cut or Torn 14 14
Contamination /Decontamination Problem 14 14
Material Integrity Problem 14 14
Fracture 10 10
Inflation Problem 10 10
Incomplete or Missing Packaging 9 9
Fluid/Blood Leak 8 8
Defective Device 7 7
Material Twisted/Bent 7 7
Tear, Rip or Hole in Device Packaging 7 7
Device Damaged Prior to Use 6 6
Pressure Problem 6 6
Moisture or Humidity Problem 5 5
Product Quality Problem 5 5
Gas Output Problem 5 5
Delivered as Unsterile Product 4 4
Infusion or Flow Problem 4 4
Moisture Damage 4 4
Device Slipped 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Insufficient Information 4 4
Output Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Material Separation 4 4
Complete Blockage 3 3
Air/Gas in Device 3 3
Separation Problem 3 3
Blocked Connection 3 3
Improper Flow or Infusion 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Misconnection 3 3
Shipping Damage or Problem 3 3
Appropriate Term/Code Not Available 3 3
Deformation Due to Compressive Stress 3 3
Loss of or Failure to Bond 2 2
Unintended Deflation 2 2
No Flow 2 2
Material Discolored 2 2
Improper or Incorrect Procedure or Method 2 2
Free or Unrestricted Flow 2 2
Device Markings/Labelling Problem 2 2
Device Alarm System 2 2
Microbial Contamination of Device 2 2
Mechanical Problem 2 2
Material Perforation 2 2
No Pressure 2 2
Unexpected Color 2 2
Material Too Rigid or Stiff 2 2
Material Fragmentation 2 2
Misassembly by Users 1 1
Patient Device Interaction Problem 1 1
Decrease in Pressure 1 1
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1
Failure of Device to Self-Test 1 1
Partial Blockage 1 1
Device Contaminated During Manufacture or Shipping 1 1
Packaging Problem 1 1
Noise, Audible 1 1
Display or Visual Feedback Problem 1 1
Firing Problem 1 1
Failure to Disconnect 1 1
Unable to Obtain Readings 1 1
Difficult to Insert 1 1
Premature Separation 1 1
Defective Alarm 1 1
Insufficient Flow or Under Infusion 1 1
Device Sensing Problem 1 1
Power Problem 1 1
Contamination 1 1
Decoupling 1 1
Compatibility Problem 1 1
Material Disintegration 1 1
Fire 1 1
Use of Device Problem 1 1
Melted 1 1
Tidal Volume Fluctuations 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Difficult to Setup or Prepare 1 1
Structural Problem 1 1
Deflation Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 570 570
Insufficient Information 75 75
No Patient Involvement 66 66
No Consequences Or Impact To Patient 43 43
No Known Impact Or Consequence To Patient 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Low Oxygen Saturation 5 5
Hypoxia 5 5
Respiratory Distress 4 4
Respiratory Insufficiency 4 4
No Information 4 4
Decreased Respiratory Rate 2 2
Hypoventilation 2 2
Viral Infection 2 2
Bacterial Infection 2 2
Bradycardia 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Death 1 1
Dyspnea 1 1
Airway Obstruction 1 1
Apnea 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Irritability 1 1
Respiratory Failure 1 1
Respiratory Distress Syndrome of Newborns 1 1
Pain 1 1
Unspecified Respiratory Problem 1 1
Test Result 1 1
Chemical Exposure 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Balance Problems 1 1
Pulmonary Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
5 Medline Industries Inc II Dec-18-2019
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