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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, continuous irrigation
Product CodeGBQ
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 2 2
2020 9 9
2021 1 1
2022 7 7
2023 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 19 19
Break 10 10
Therapeutic or Diagnostic Output Failure 5 5
Physical Resistance/Sticking 5 5
Gas/Air Leak 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 2 2
Air/Gas in Device 2 2
Leak/Splash 2 2
Difficult to Remove 2 2
Failure to Advance 1 1
Separation Failure 1 1
Failure to Cut 1 1
Unsealed Device Packaging 1 1
Entrapment of Device 1 1
Lack of Effect 1 1
Explosion 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 6 6
Device Embedded In Tissue or Plaque 2 2
Hemorrhage/Bleeding 2 2
Failure of Implant 2 2
Pain 2 2
Pneumothorax 2 2
Obstruction/Occlusion 1 1
Death 1 1
Unspecified Infection 1 1
Hemothorax 1 1
Hypovolemic Shock 1 1
No Code Available 1 1
Unspecified Kidney or Urinary Problem 1 1

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