• 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 system, blood collection, vacuum-assisted, manual
Product CodeKST
Regulation Number 864.9125
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 7 7
2019 5 5
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 6 6
Leak/Splash 5 5
Fluid Leak 3 3
Appropriate Term/Code Not Available 3 3
Break 2 2
Defective Device 2 2
Detachment of Device or Device Component 1 1
Gas Leak 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blood Loss 5 5
No Known Impact Or Consequence To Patient 4 4
No Information 3 3
No Consequences Or Impact To Patient 2 2
Hemorrhage/Bleeding 1 1
No Patient Involvement 1 1

-
-