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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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 43 43
Suction Failure 9 9
Suction Problem 8 8
Break 4 4
Disconnection 3 3
Material Separation 3 3
Leak/Splash 3 3
Defective Device 3 3
Fitting Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Gas/Air Leak 3 3
Material Twisted/Bent 3 3
Pressure Problem 3 3
Appropriate Term/Code Not Available 2 2
Device Contaminated During Manufacture or Shipping 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
Separation Problem 1 1
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
No Flow 1 1
Output Problem 1 1
Noise, Audible 1 1
Ejection 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 76 76
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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