inforMED
MalfunctionFPK

MEDEX

Received Aug 6, 2021 · Event occurred Jun 29, 2021

Report 3012307300-2021-08160 · MDR key 12291323

Device

Generic name

Intravenous Extension Tubing Set

Model number

MX450FL

Lot number

4072121

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE END OF THE DEVICE HAS PULLED OFF MULTIPLE TIMES CAUSING FLUID INCLUDING BLOOD TO BE LOST.