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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 9 9
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 21 21
Fluid Leak 7 7
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 3 3
Device Operates Differently Than Expected 3 3
No Apparent Adverse Event 3 3
Loose or Intermittent Connection 3 3
Break 3 3
Crack 3 3
Disconnection 3 3
Material Disintegration 2 2
Split 2 2
Insufficient Information 2 2
Defective Device 2 2
Accessory Incompatible 1 1
Free or Unrestricted Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Physical Resistance 1 1
Difficult to Flush 1 1
Particulates 1 1
Material Separation 1 1
Device Slipped 1 1
Defective Component 1 1
Failure to Deliver 1 1
Restricted Flow rate 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
No Known Impact Or Consequence To Patient 12 12
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 5 5
Blood Loss 4 4
Hemorrhage/Bleeding 4 4
No Information 3 3
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Therapeutic Response, Decreased 1 1
Chemical Exposure 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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