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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
2017 15 15
2018 9 9
2019 10 10
2020 4 4
2021 8 8
2022 7 7
2023 15 15
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 21 21
Defective Component 11 11
Fluid/Blood Leak 11 11
No Flow 10 10
Suction Failure 8 8
Break 6 6
Disconnection 5 5
Detachment of Device or Device Component 5 5
Device Contamination with Chemical or Other Material 4 4
Crack 3 3
Defective Device 3 3
No Apparent Adverse Event 3 3
Device Operates Differently Than Expected 3 3
Loose or Intermittent Connection 3 3
Split 2 2
Material Disintegration 2 2
Complete Blockage 2 2
Insufficient Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Particulates 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance 1 1
Physical Resistance/Sticking 1 1
Accessory Incompatible 1 1
Restricted Flow rate 1 1
Unintended Movement 1 1
Difficult to Flush 1 1
Suction Problem 1 1
Device Slipped 1 1
Material Split, Cut or Torn 1 1
Failure to Deliver 1 1
Use of Device Problem 1 1
Material Separation 1 1
Free or Unrestricted Flow 1 1
Improper or Incorrect Procedure or Method 1 1
Component Falling 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Consequences Or Impact To Patient 17 17
No Known Impact Or Consequence To Patient 12 12
Insufficient Information 8 8
Blood Loss 4 4
No Information 3 3
Hemorrhage/Bleeding 3 3
Chemical Exposure 2 2
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
Therapeutic Response, Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hospira Inc. II Jan-11-2017
2 Medtronic Inc. II Nov-18-2017
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