MalfunctionDXT
FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES
Received Nov 8, 2023 · Event occurred Sep 17, 2023
Report 18091967 · MDR key 18091967
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Bracco Injeneering SaModel number
017355Catalog number
017355
Lot number
240898
Patient
13505 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE INJECTING A PATIENT WITH IV CONTRAST, THE BRACCO INJECTOR SYRINGE BROKE COMPLETELY FREE FROM THE HEAD UNIT AND THE PLUNGER SEPARATED THE SYRINGE CYLINDER FROM THE LOCKING DISC AT THE BASE. THIS FAILURE SENT THE SYRINGE HURTLING TOWARD THE PATIENT LIKE A PROJECTILE. THE ATTACHED EXTENSION TUBING PREVENTED IT FROM STRIKING THE PATIENT