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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device connector, blood tubing, infusion t
Product CodeFKB
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Inadequate User Interface 2 2
Collapse 1 1
Disconnection 1 1
Fire 1 1
Loose or Intermittent Connection 1 1
Device Contamination with Body Fluid 1 1
Improper Flow or Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Exposure to Body Fluids 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Perrigo Diabetes Care II Feb-19-2014
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