inforMED
MalfunctionDXT

FASTLOAD¿ CT SYRINGE PACK WITH SPIKE

Received May 7, 2026 · Event occurred Feb 11, 2026

Report 25111066 · MDR key 25111066

Device

Generic name

Injector And Syringe, Angiographic

Model number

017345

Catalog number

017345

Lot number

287316

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

MULTIPLE BRACCO SINGLE CT INJECTOR KITS HAVE MALFUNCTIONED DURING USE. THE FIRST INCIDENT WAS [REDACTED]-AT THE END OF JANUARY WITH AN INJECTOR MALFUNCTIONING WHILE LOADING THE INJECTOR. SECOND INCIDENT WAS THE INJECTOR KIT HAD MALFUNCTION OR WAS PROCESSED BROKEN PRIOR TO OPENING THE PACKAGE.