Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device tubing, fluid delivery
Product CodeFPK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2019 10 10
2020 4 4
2021 8 8
2022 7 7
2023 15 15
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 11 11
Defective Component 11 11
No Flow 10 10
Fluid/Blood Leak 9 9
Suction Failure 8 8
Break 4 4
Disconnection 4 4
Defective Device 3 3
Detachment of Device or Device Component 3 3
Complete Blockage 2 2
Crack 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Restricted Flow rate 1 1
Particulates 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Free or Unrestricted Flow 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Accessory Incompatible 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 6 6
No Consequences Or Impact To Patient 5 5
Blood Loss 3 3
Hemorrhage/Bleeding 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
No Patient Involvement 1 1
Therapeutic Response, Decreased 1 1
Chemical Exposure 1 1

-
-