inforMED
MalfunctionDXT

FASTLOAD CTA DUAL SYRINGE PACK

Received Mar 24, 2025 · Event occurred Mar 18, 2025

Report 21676108 · MDR key 21676108

Device

Generic name

Injector And Syringe, Angiographic

Model number

017354

Catalog number

017354

Lot number

263142

Patient

40 YR · Female

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Narrative

Description of Event or Problem

INJECTOR WAS LOADED WITH CONTRAST & SALINE WITHOUT ANY ISSUES. WHEN THE TUBING WAS PRIMED TO GET RID OF THE AIR BUBBLES, THE SALINE SIDE WOULD NOT MOVE BUT YOU COULD STILL HEAR THE MOTOR ATTEMPTING TO RUN. WE THEN DECIDED TO UNLOAD BOTH SYRINGES AND TRY A NEW SET. ON THE INJECTOR SCREEN, REPLACE SYRINGE WAS SELECTED AND DUAL WAS SELECTED. ONCE THE PISTONS ATTEMPTED TO PULL BACK, THE SALINE SIDE OF SYRINGE EXPLODED. PART OF THE SYRINGE SHEARED OFF AND ALMOST HIT THE TECHS IN THE ROOM. THE PATIENT WAS IN THE ROOM DURING THIS TIME, THE PATIENT WAS NOT INJURED OR HARMED IN ANY WAY.