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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, fluid delivery
Product CodeFPK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2018 9 9
2019 10 10
2020 4 4
2021 8 8
2022 7 7
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 15 15
Defective Component 11 11
Fluid/Blood Leak 10 10
No Flow 10 10
Suction Failure 8 8
Detachment of Device or Device Component 4 4
Break 4 4
Defective Device 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Complete Blockage 2 2
Crack 2 2
Disconnection 2 2
Device Operates Differently Than Expected 2 2
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Difficult to Flush 1 1
Failure to Deliver 1 1
Physical Resistance 1 1
Restricted Flow rate 1 1
Detachment Of Device Component 1 1
Particulates 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Accessory Incompatible 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 5 5
No Information 3 3
Blood Loss 3 3
Hemorrhage/Bleeding 3 3
Chemical Exposure 2 2
Exposure to Body Fluids 1 1
Therapeutic Response, Decreased 1 1
No Patient Involvement 1 1

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