MalfunctionDXT
FASTLOAD¿ CT SYRINGE PACK
Received Jan 6, 2025 · Event occurred Nov 25, 2024
Report 21078676 · MDR key 21078676
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Bracco Injeneering S.a.Model number
017344Catalog number
017344
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INJECTOR SYRINGES BROKE AWAY FROM INJECTOR AND SHOT OFF IN THE DIRECTION OF PATIENTS ON AT LEAST FOUR SEPARATE OCCASIONS. PACKAGING FROM THE TWO CANISTERS HAD CRUSH MARKINGS ON THEM, SO STAFF EXAMINED THE REST OF THE SUPPLY AND NOTICED SEVERAL OTHER CANISTERS WITH THE SAME CRUSH MARKINGS. STAFF PULLED ALL AFFECTED STOCK AND NOTIFIED THEIR LEADER WHO WAS ABLE TO NOTIFY SUPPLY CHAIN. SUPPLY CHAIN INVESTIGATED AND DECIDED TO PULL THE ENTIRE LOT. THEY REPLACED THE PRODUCT QUICKLY AND INFORMED THE SUPPLIER OF THE ISSUE.