MalfunctionIWW
SIROS D-VIAL PREP SET
Received Feb 25, 2026 · Event occurred Jan 27, 2026
Report 9710358-2026-00003 · MDR key 24445039
Device
Generic name
System, Applicator, Radionuclide, Manual
Manufacturer
Sirtex Medical, Inc.Model number
SIR-10200Lot number
11428139
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.
Description of Event or Problem
DURING THE ADMINISTRATION OF SIR-SPHERES, THE TOP OF THE D-VIAL STARTED LEAKING. THIS WAS OBSERVED AFTER THE FIRST ALIQUOT OF THE DOSE.