• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 129 129
Leak/Splash 117 117
Product Quality Problem 104 104
Gas Leak 99 99
Crack 29 29
Loose or Intermittent Connection 22 22
Connection Problem 16 16
Detachment of Device or Device Component 16 16
Fitting Problem 16 16
Defective Component 14 14
Material Puncture/Hole 10 10
Material Integrity Problem 10 10
Break 9 9
Component Missing 9 9
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
Inflation Problem 5 5
Obstruction of Flow 5 5
Contamination /Decontamination Problem 5 5
Device Displays Incorrect Message 4 4
Device Operates Differently Than Expected 4 4
Device Damaged Prior to Use 4 4
Material Separation 4 4
Insufficient Information 4 4
Material Twisted/Bent 4 4
Pressure Problem 3 3
Separation Problem 3 3
Air/Gas in Device 3 3
Tear, Rip or Hole in Device Packaging 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Misconnection 3 3
Delivered as Unsterile Product 3 3
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
Infusion or Flow Problem 2 2
No Flow 2 2
No Pressure 2 2
Blocked Connection 2 2
Defective Device 2 2
Failure to Deliver 2 2
Microbial Contamination of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Perforation 2 2
Improper or Incorrect Procedure or Method 2 2
Unintended Deflation 2 2
Physical Resistance/Sticking 2 2
Noise, Audible 2 2
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Moisture or Humidity Problem 1 1
Premature Separation 1 1
Insufficient Flow or Under Infusion 1 1
Tidal Volume Fluctuations 1 1
Use of Device Problem 1 1
Failure to Disconnect 1 1
Deformation Due to Compressive Stress 1 1
Difficult to Open or Close 1 1
Device Markings/Labelling Problem 1 1
Packaging Problem 1 1
Power Problem 1 1
Improper Flow or Infusion 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
Difficult to Remove 1 1
Decrease in Pressure 1 1
Moisture Damage 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Melted 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 235 235
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 4 4
Foreign Body In Patient 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Viral Infection 2 2
Extubate 1 1
Irritability 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Cardiopulmonary Arrest 1 1
Death 1 1
Dyspnea 1 1
Pulmonary Edema 1 1
Awareness during Anaesthesia 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Patient Problem/Medical Problem 1 1
Swelling 1 1
No Code Available 1 1
Test Result 1 1

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