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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)
Regulation Description Anesthesia breathing circuit.
Product CodeCAI
Regulation Number 868.5240
Device Class 1

MDR Year MDR Reports MDR Events
2021 138 140
2022 244 244
2023 251 251
2024 118 119
2025 108 108
2026 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 267 267
Leak/Splash 157 157
Material Puncture/Hole 55 55
Loose or Intermittent Connection 36 37
Break 33 33
Crack 32 32
Connection Problem 26 26
Defective Component 22 22
Obstruction of Flow 20 20
Material Deformation 20 20
Component Missing 19 19
Material Split, Cut or Torn 17 17
Disconnection 16 16
Material Integrity Problem 16 16
Detachment of Device or Device Component 15 15
Failure to Deliver 14 14
Fluid/Blood Leak 13 13
Contamination /Decontamination Problem 13 13
Fracture 12 12
Insufficient Information 12 12
Inflation Problem 10 10
Material Twisted/Bent 9 9
Incomplete or Missing Packaging 9 9
Incomplete or Inadequate Connection 8 8
Defective Device 8 8
Fitting Problem 7 7
Material Separation 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Damaged Prior to Use 6 6
Pressure Problem 6 6
Separation Failure 5 5
Moisture Damage 5 5
Product Quality Problem 5 5
Complete Blockage 4 4
Contamination 4 4
Inadequacy of Device Shape and/or Size 4 4
Output Problem 4 4
Delivered as Unsterile Product 4 4
Device Slipped 4 4
Moisture or Humidity Problem 4 4
Appropriate Term/Code Not Available 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Alarm System 3 3
Air/Gas in Device 3 3
Material Fragmentation 3 3
Shipping Damage or Problem 3 3
Mechanical Problem 3 3
Separation Problem 3 4
Deformation Due to Compressive Stress 3 3
Improper Flow or Infusion 3 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 747 750
Insufficient Information 84 85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Low Oxygen Saturation 10 10
Unspecified Infection 8 8
No Patient Involvement 7 7
Hypoventilation 6 6
No Consequences Or Impact To Patient 6 6
Respiratory Insufficiency 4 4
Ventilator Dependent 4 4
Hypoxia 3 3
Respiratory Arrest 2 2
Viral Infection 2 2
Bacterial Infection 2 2
Pulmonary Hypertension 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Foreign Body In Patient 1 1
Burn(s) 1 1
Dyspnea 1 1
Pain 1 1
Balance Problems 1 1
Bradycardia 1 1
Increased Respiratory Rate 1 1
Unspecified Respiratory Problem 1 1
Irritability 1 1
Respiratory Distress Syndrome of Newborns 1 1
Decreased Respiratory Rate 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 Draeger, Inc. I Apr-03-2025
3 MEDLINE INDUSTRIES, LP - Northfield I Sep-19-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-19-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
15 Medline Industries, LP II Apr-01-2026
16 Medline Industries, LP II Feb-17-2026
17 Medline Industries, LP II Feb-09-2026
18 Medline Industries, LP II Feb-06-2026
19 Medline Industries, LP II Jan-12-2026
20 Medline Industries, LP I Nov-13-2025
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