inforMED
MalfunctionGBS

AXIOM ATRAUM THORACIC CATHETER

Received Oct 22, 2021 · Event occurred Oct 19, 2021

Report MW5104904 · MDR key 12689148

Device

Generic name

Catheter, Ventricular, General & Plastic Surgery

Lot number

1902409

Product problems

  • Particulates

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

STAFF OBTAINED A CHEST TUBE AND UPON OPENING DISCOVERED THAT THE TUBE APPEARED TO HAVE PLASTIC PARTICLES INSIDE THE TUBE. THE TUBE WAS NOT USED AND PLACED ASIDE. FDA SAFETY REPORT ID # (B)(4).