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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
2014 62 62
2015 32 32
2016 164 164
2017 154 154
2018 39 39
2019 62 62
2020 71 71
2021 138 138
2022 244 244
2023 251 251
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 259 259
Gas/Air Leak 255 255
Disconnection 173 173
Product Quality Problem 105 105
Crack 91 91
Break 51 51
Loose or Intermittent Connection 50 50
Material Puncture/Hole 44 44
Connection Problem 27 27
Material Deformation 23 23
Defective Component 23 23
Component Missing 23 23
Detachment of Device or Device Component 22 22
Air Leak 21 21
Obstruction of Flow 19 19
Fitting Problem 18 18
Device Operates Differently Than Expected 17 17
Material Integrity Problem 16 16
Failure to Deliver 16 16
Fracture 15 15
Device Alarm System 14 14
Contamination /Decontamination Problem 14 14
Material Split, Cut or Torn 14 14
Detachment Of Device Component 12 12
Fluid/Blood Leak 10 10
Inflation Problem 10 10
Material Separation 10 10
Occlusion Within Device 10 10
Incomplete or Missing Packaging 9 9
Melted 9 9
Degraded 8 8
Hole In Material 8 8
Tear, Rip or Hole in Device Packaging 8 8
Device Displays Incorrect Message 8 8
Pressure Problem 8 8
Material Twisted/Bent 7 7
Infusion or Flow Problem 7 7
Defective Device 7 7
No Flow 6 6
Insufficient Information 6 6
Device Damaged Prior to Use 6 6
Moisture Damage 5 5
Inadequacy of Device Shape and/or Size 5 5
Gas Output Problem 5 5
Partial Blockage 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Improper Flow or Infusion 5 5
Moisture or Humidity Problem 5 5
Cut In Material 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Output Problem 4 4
Loss of or Failure to Bond 4 4
Device Slipped 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Delivered as Unsterile Product 4 4
Misconnection 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Material Perforation 3 3
Shipping Damage or Problem 3 3
Material Rupture 3 3
Tidal Volume Fluctuations 3 3
Microbial Contamination of Device 3 3
Complete Blockage 3 3
Deflation Problem 3 3
Fire 3 3
Kinked 3 3
High Test Results 3 3
Failure to Disconnect 3 3
Blocked Connection 3 3
Deformation Due to Compressive Stress 3 3
Difficult to Open or Close 3 3
Appropriate Term/Code Not Available 3 3
Separation Problem 3 3
Misassembly by Users 3 3
Air/Gas in Device 3 3
Unexpected Color 2 2
Unintended Deflation 2 2
Physical Resistance/Sticking 2 2
Noise, Audible 2 2
Torn Material 2 2
Device Sensing Problem 2 2
Device Markings/Labelling Problem 2 2
Free or Unrestricted Flow 2 2
No Pressure 2 2
Misassembled 2 2
Mechanical Problem 2 2
Material Discolored 2 2
Material Fragmentation 2 2
Tears, rips, holes in device, device material 2 2
Overheating of Device 2 2
Material Too Rigid or Stiff 2 2
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Smoking 1 1
Sticking 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Insufficient Flow or Under Infusion 1 1
Knotted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 569 569
No Known Impact Or Consequence To Patient 234 234
No Patient Involvement 145 145
No Consequences Or Impact To Patient 137 137
Insufficient Information 76 76
Low Oxygen Saturation 23 23
No Information 14 14
Respiratory Distress 11 11
Hypoxia 11 11
Hypoventilation 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Dyspnea 5 5
Bradycardia 5 5
Pressure Sores 4 4
Respiratory Insufficiency 4 4
Burn(s) 3 3
Bacterial Infection 2 2
Awareness during Anaesthesia 2 2
Asphyxia 2 2
Cardiopulmonary Arrest 2 2
Cyanosis 2 2
Death 2 2
Extubate 2 2
Viral Infection 2 2
Decreased Respiratory Rate 2 2
No Code Available 2 2
Balance Problems 1 1
Pulmonary Hypertension 1 1
Unspecified Respiratory Problem 1 1
Test Result 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Respiratory Failure 1 1
Irritability 1 1
Choking 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Brain Injury 1 1
Cardiac Tamponade 1 1
Headache 1 1
Nausea 1 1
Pain 1 1
Perforation 1 1
Pulmonary Edema 1 1
Apnea 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Airway Obstruction 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 GE Medical Systems, LLC II Sep-09-2009
3 Impact Instrumentation, Inc. II Jan-12-2012
4 Instrumentation Industries Inc II Dec-29-2013
5 Intersurgical Inc II Jun-27-2018
6 King Systems Corp. I Sep-27-2013
7 King Systems Corp. II Feb-03-2009
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
11 Medline Industries Inc II Dec-18-2019
12 Teleflex Medical I Sep-30-2014
13 Teleflex Medical II Jul-23-2014
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