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