inforMED
MalfunctionFMF

SINGLE DOSE INJECTION PEN

Received Dec 15, 2023 · Event occurred Sep 13, 2023

Report MW5149307 · MDR key 18344941

Device

Generic name

Syringe, Piston

Lot number

D629011V

Patient

30 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

REPORTER CALLED TO REPORT THAT TWO OF HER SINGLE DOSE INJECTOR PENS MALFUNCTIONED ON THE SAME DAY. THE FIRST INJECTOR PEN EJECTED THE NEEDLE INTO HER SKIN BUT NO MEDICATION WAS DELIVERED. THE MEDICATION COULD BE SEEN IN THE NEEDLE BUT NOTHING CAME OUT. THE SECOND INJECTOR PEN, UPON TAKING OUT TO USE - DUE TO FAILURE OF THE FIRST PEN - HAD MEDICATION LEAKING OUT OF THE SYRINGE NEEDLE, SO THE REPORTER MADE THE DECISION (PER MANUFACTURER INSTRUCTIONS) NOT TO USE IT AS A RESULT OF IT BEING COMPROMISED. REF REPORT: MW5149308.