• 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
2018 39 39
2019 62 62
2020 71 71
2021 138 138
2022 244 244

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 130 130
Gas/Air Leak 114 114
Material Puncture/Hole 22 22
Loose or Intermittent Connection 21 21
Crack 21 21
Defective Component 20 20
Material Deformation 18 18
Disconnection 18 18
Detachment of Device or Device Component 16 16
Fitting Problem 16 16
Connection Problem 14 14
Break 13 13
Material Integrity Problem 11 11
Component Missing 10 10
Material Split, Cut or Torn 9 9
Contamination /Decontamination Problem 8 8
Inflation Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Fluid/Blood Leak 6 6
Gas Output Problem 5 5
Obstruction of Flow 5 5
Material Twisted/Bent 4 4
Device Damaged Prior to Use 4 4
Device Slipped 4 4
Fracture 4 4
Product Quality Problem 4 4
Pressure Problem 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 3 3
Separation Problem 3 3
Air/Gas in Device 3 3
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
Incomplete or Missing Packaging 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Operates Differently Than Expected 3 3
Infusion or Flow Problem 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
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
Unintended Deflation 2 2
Physical Resistance/Sticking 2 2
No Flow 2 2
No Pressure 2 2
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
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
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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 337 337
No Patient Involvement 73 73
No Consequences Or Impact To Patient 50 50
No Known Impact Or Consequence To Patient 33 33
Insufficient Information 22 22
Hypoxia 7 7
Low Oxygen Saturation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Respiratory Distress 6 6
No Information 4 4
Foreign Body In Patient 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 Failure 1 1
Decreased Respiratory Rate 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Patient Problem/Medical Problem 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
No Code Available 1 1
Balance Problems 1 1
Test Result 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
-
-