SIROS D-VIAL PREP SET
Received Mar 24, 2026 · Event occurred Feb 24, 2026
Report 9710358-2026-00009 · MDR key 24681209
Device
Generic name
System, Applicator, Radionuclide, Manual
Manufacturer
Sirtex Medical, Inc.Model number
SIR-10200Lot number
11428160
Product problems
- No Apparent Adverse Event
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
PRIOR TO THE ADMINISTRATION, DURING THE SET-UP PROCESS, THE PHYSICIAN CRACKED THE D LINE CONNECTION THAT ATTACHES TO THE D VIAL. A NEW D LINE WAS TAKEN FROM A NEW DELIVERY SET, PRIMED AND CONNECTED AS NORMAL. HALFWAY THROUGH THE DELIVERY IT WAS NOTICED THAT A COLUMN OF WATER WAS FORMING OUTSIDE OF THE D-VIAL BUT WAS CONTAINED IN THE ACRYLIC SHIELDING OF THE VIAL. THERE WAS NO VORTEX FORMING TO SUSPEND THE SPHERES AND D5W WAS STILL ABLE TO BE PUSHED THROUGH AND OUT OF THE MICRO CATHETER. THERE WAS NO ISSUE PUSHING CONTRAST THROUGH THE B LINE. IT WAS STATED THAT A 20CC SYRINGE WAS USED ON D LINE, A 10CC SYRINGE USED ON B LINE, AND A .021 MICRO CATHETER WAS USED DURING ADMINISTRATION. NO CLUMPING OF SPHERES WAS OBSERVED IN THE D VIAL OR IN THE COLUMN OF WATER. IT WAS STATED THAT 94% OF DOSE WAS ADMINISTERED TO PATIENT AND THAT THE DEVICE WOULD BE RETURNED AFTER THE DECAY PERIOD.