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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peritoneal dialysis, single use
Product CodeFKO
Regulation Number 876.5630
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2017 11 11
2019 2 2
2021 6 6
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 7 7
Break 3 3
Improper or Incorrect Procedure or Method 3 3
Fluid/Blood Leak 2 2
Hole In Material 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 1 1
Corroded 1 1
Leak/Splash 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Volume Accuracy Problem 1 1
Device Displays Incorrect Message 1 1
Chemical Spillage 1 1
Detachment of Device or Device Component 1 1
Device Disinfection Or Sterilization Issue 1 1
Gas/Air Leak 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
Insufficient Information 6 6
Peritonitis 4 5
Unspecified Infection 2 3
Sepsis 1 2
Skin Irritation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Injury 1 1
Superficial (First Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Death 1 1

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