MalfunctionFMF
SINGLE DOSE INJECTION PEN
Received Dec 15, 2023 · Event occurred Sep 13, 2023
Report MW5149308 · MDR key 18344980
Device
Generic name
Syringe, Piston
Lot number
D575488G
Patient
30 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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: MW5149307.