MalfunctionFPA
BD SMARTSITE LOW SORBING EXTENSION SET
Received Mar 23, 2026 · Event occurred Mar 13, 2026
Report MW5185572 · MDR key 24662721
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Isomedix Operations Inc./steris CorporationModel number
20350ELot number
25105525
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BD SMARTSITE LOW SORBING EXTENSION SET 0.2 MICRON FILTER HAS BEEN CLOGGING/MALFUNCTIONING WHILE INFUSING ON PATIENTS. RESULTING IN THE INFUSION STOPPING AND CAUSING LENGTHENING OF TREATMENT TIME.