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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
2020 71 71
2021 138 138
2022 244 244
2023 251 251
2024 117 118

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 230 230
Leak/Splash 158 158
Material Puncture/Hole 46 46
Loose or Intermittent Connection 42 43
Crack 29 29
Break 28 28
Defective Component 22 22
Connection Problem 21 21
Material Deformation 21 21
Component Missing 19 19
Fitting Problem 17 17
Detachment of Device or Device Component 17 17
Obstruction of Flow 17 17
Disconnection 15 15
Material Integrity Problem 15 15
Material Split, Cut or Torn 14 14
Failure to Deliver 14 14
Contamination /Decontamination Problem 13 13
Insufficient Information 12 12
Inflation Problem 10 10
Fluid/Blood Leak 9 9
Incomplete or Missing Packaging 9 9
Material Twisted/Bent 9 9
Fracture 8 8
Defective Device 7 7
Pressure Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Damaged Prior to Use 6 6
Product Quality Problem 5 5
Inadequacy of Device Shape and/or Size 4 4
Material Separation 4 4
Delivered as Unsterile Product 4 4
Moisture or Humidity Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Moisture Damage 4 4
Device Slipped 4 4
Output Problem 4 4
Air/Gas in Device 3 3
Shipping Damage or Problem 3 3
Deformation Due to Compressive Stress 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Appropriate Term/Code Not Available 3 3
Complete Blockage 3 3
Device Alarm System 3 3
Separation Problem 3 3
Microbial Contamination of Device 2 2
Contamination 2 2
Material Fragmentation 2 2
Material Discolored 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 642 643
Insufficient Information 77 77
No Patient Involvement 40 40
No Consequences Or Impact To Patient 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Unspecified Infection 8 8
Low Oxygen Saturation 5 5
No Known Impact Or Consequence To Patient 4 4
Respiratory Insufficiency 4 4
Hypoventilation 2 2
No Information 2 2
Viral Infection 2 2
Hypoxia 2 2
Bacterial Infection 2 2
Pulmonary Hypertension 1 1
Apnea 1 1
Arrhythmia 1 1
Death 1 1
Test Result 1 1
Aspiration/Inhalation 1 1
Burn(s) 1 1
Foreign Body In Patient 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Pain 1 1
Balance Problems 1 1
Bradycardia 1 1
Unspecified Respiratory Problem 1 1
Respiratory Distress Syndrome of Newborns 1 1
Irritability 1 1
Airway Obstruction 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
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
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