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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, a-v shunt
Product CodeFIQ
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2 2
Difficult to Remove 2 2
Detachment of Device or Device Component 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Break 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Death 1 1
Failure of Implant 1 1
No Code Available 1 1

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