inforMED
MalfunctionFOZ

INTROCAN SAFETY 2

Received Jul 21, 2026 · Event occurred Jul 1, 2026

Report 25891025 · MDR key 25891025

Device

Generic name

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Lot number

25N11G8C33

Patient

20 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ATTEMPTED TO FLUSH MEDICATIONS THROUGH A 20G IV AND CLAVE WHILE IN MRI. PT WAS A LVL [LEVEL] 1 STROKE AND WAS VERY AGITATED. WAS UNABLE TO FLUSH WITH THE CLAVE ON. WAS ABLE TO FLUSH WITHOUT THE CLAVE. EXCHANGED CLAVE AND STILL WAS UNABLE TO FLUSH. WAS ONLY ABLE TO GIVE MEDS/FLUSH WITHOUT THE CLAVE WITH A 3 ML HOOKED DIRECTLY TO THE CATHETER. AFTER RETURNING TO ED HAD TO D/C [DISCONTINUE] CATHETER AND PLACE A NEW IV.