inforMED
MalfunctionKYX

MINI SPIKE DISP PIN

Received Feb 10, 2026

Report MW5183652 · MDR key 24307589

Device

Generic name

Dispenser, Liquid Medication

Patient

NA · Female

  • Diarrhea
  • Headache

Narrative

Description of Event or Problem

PT REPORTS EXPERIENCING HEADACHES AND DIARRHEA, TAKES FIORICET AND IMODIUM TO RELIEVE. PT ALSO REPORTED THEIR MINI SPIKE DISPENSE PIN CAUSED REMODULIN TO LEAK FROM VIAL. PRODUCT LOT NUMBER UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. MD IS AWARE. IV REMODULIN PT VIA CADD SOLIS PUMP. DIAGNOSIS FOR USE: PULMONARY ARTERIAL HYPERTENSION.