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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, noninvasive
Product CodeGAZ
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2019 23 23
2020 25 25
2021 18 18
2022 12 12
2023 25 25
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 43 43
Suction Failure 8 8
Suction Problem 8 8
Break 4 4
Disconnection 3 3
Material Separation 3 3
Leak/Splash 3 3
Pressure Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Gas/Air Leak 3 3
Material Twisted/Bent 3 3
Defective Device 3 3
Fitting Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Appropriate Term/Code Not Available 2 2
Material Rupture 2 2
Filling Problem 2 2
Fluid/Blood Leak 2 2
Decrease in Suction 2 2
Key or Button Unresponsive/not Working 2 2
Backflow 1 1
Complete Blockage 1 1
Failure to Conduct 1 1
Inability to Irrigate 1 1
Unintended Ejection 1 1
Insufficient Flow or Under Infusion 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Energy Output Problem 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Noise, Audible 1 1
Separation Problem 1 1
No Flow 1 1
Output Problem 1 1
Defective Component 1 1
Component Missing 1 1
Failure to Advance 1 1
Failure to Cut 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
No Consequences Or Impact To Patient 22 22
No Known Impact Or Consequence To Patient 9 9
No Patient Involvement 5 5
No Information 3 3
Insufficient Information 2 2
Foreign Body In Patient 1 1
Hemorrhage/Bleeding 1 1
Vitreous Hemorrhage 1 1

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