• 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 Back To Search Results
Device injector, pen
Regulation Description Piston syringe.
Definition A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.
Product CodeNSC
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ELI LILLY AND CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 11
No display or display failure 7
Device operates differently than expected 6
Failure to deliver 4
Use of Device Issue 3
Difficult or delayed activation 3
No Information 3
Blockage within device or device component 2
Mechanical jam 2
Battery issue 2
Incorrect or inadequate test results 2
High test results 2
Improper or incorrect procedure or method 2
Sticking 2
Unexpected therapeutic results 1
Device inoperable 1
Crack 1
Fluid leak 1
Mechanical issue 1
Poor quality image 1
Device Difficult to Setup or Prepare 1
Shelf life exceeded 1
Slippage of device or device component 1
Inaccurate delivery 1
Defective item 1
Device markings issue 1
Human-Device Interface Issue 1
Inaccurate dispensing 1
No flow 1
No Known Device Problem 1
Total Device Problems 67

-
-