MalfunctionKYX
MINI SPIKE DISP PIN
Received Feb 10, 2026
Report MW5183652 · MDR key 24307589
Device
Generic name
Dispenser, Liquid Medication
Manufacturer
B. Braun Medical Inc.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.