inforMED
MalfunctionDXT

FASTLOAD CTA DUAL SYRINGE PACK

Received Mar 25, 2025 · Event occurred Mar 21, 2025

Report 21686649 · MDR key 21686649

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Product code (DXT)
Manufacturer (Bracco Injeneering S.a.)
Model (017354)

Device

Generic name

Injector And Syringe, Angiographic

Model number

017354

Catalog number

017354

Lot number

268541

Patient

64 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

INJECTOR WAS FILLED PER PROTOCOL WITHOUT ANY ISSUES. PATIENT WAS HOOKED TO THE INJECTOR FOR THE SCAN. WHEN THE TECH STARTED THE INJECTION, THEY HEARD A "POP", THE TECH IMMEDIATELY STOPPED THE INJECTOR (IT DID NOT STOP ON ITS OWN). UPON INVESTIGATING THE SYRINGE WAS BUSTED ON THE CONTRAST SIDE. THE TECH UNHOOKED FROM THE TUBING AND REMOVED ALL PIECES. INFORMATION WAS SENT TO BRACCO & RISK MANAGEMENT. THE PATIENT WAS NOT HARMED BY THIS ERROR. PATIENT'S SCAN WAS THEN FINISHED WITHOUT ANY OTHER ISSUES. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SERVICE STAFF COMING TO INSPECT.