inforMED
MalfunctionOEI

EXPEL¿ MULTO-PURPOSE DRAINAGE CATHETER

Received Sep 26, 2017 · Event occurred Aug 3, 2017

Report 6893949 · MDR key 6893949

Device

Generic name

Drainage Catheter

Model number

39311-105

Lot number

20546327

Product problems

  • Crack

Patient

37 YR

  • Abscess
  • Abscess

Narrative

Description of Event or Problem

PATIENT RETURNED TO HOSPITAL FOR DRESSING CHANGE DUE TO LEAKING ABSCESS DRAIN PLACED IN IR CT. THE TUBING AND STOPCOCK WERE NOT THE SOURCE OF THE LEAK. AFTER RT EVALUATED TUBE THE LEAK WAS FROM THE CATHETER HUB BEING CRACKED. PATIENT WAS KEPT AND PRE PROCEDURE WORK DONE IN SPEC PROCEDURE HOLDING AREA. DR. ORDERED FOR DRAINAGE CATHETER EXCHANGE AND TUBE WAS EXCHANGED UNDER X-RAY GUIDANCE. PATIENT WAS RECOVERED POST PROCEDURE.