inforMED
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

Model number

017344

Catalog 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.