inforMED
MalfunctionDXT

ACIST ANGIOTOUVH KIT P65

Received Dec 30, 2025

Report MW5181425 · MDR key 23922414

Device

Generic name

Injector And Syringe, Angiographic

Lot number

26725F

Product problems

  • Material Fragmentation
  • Contamination /Decontamination Problem

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

WHILE OPENING A SINGLE USE PRODUCT PREPROCEDURAL, ONE OF THE ITEMS (ACIST HANDLE CONTROLLER AND PATIENT TUBING) HAD VISIBLE, LOOSE DEBRIS ON THE PATIENT TUBING. THE DEBRIS APPEARED TO BE METALLIC IN NATURE. ITS STERILITY WAS IN QUESTION, AND IT WAS DECIDED TO STOP SETUP AND OPEN A NEW TRAY. THE ITEM IN QUESTION WAS RETAINED. ACIST ANGIOTOUVH KIT P65 REF: 014645 LOT: 26725F.