inforMED
MalfunctionEYZ

PECO TOUCH-FREE CATHETERIZATION SYSTEM

Received Oct 13, 2014

Report MW5038594 · MDR key 4181750

Device

Generic name

Peco Touch-free Catheterization System

Manufacturer

Peco Medical, Inc.

Model number

PK5214

Lot number

1112121E

Product problems

  • Shelf Life Exceeded

Patient

52 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

RECEIVED PECO TOUCH-FREE CATHETERIZATION SYSTEM, REF PK5214, LOT 1112121E, EXPIRY DATE 12//11/2014 (WHICH I UNDERSTAND IS DECEMBER 2014) BURT THE POVIDONE-IODINE SWABS ARE ALREADY EXPIRED. THE APLICARE PVP INSIDE THE URINARY CATHETER KITS ARE EXPIRED. WITHPVP-IODINE SWAB (B)(4) FROM APLICARE WITH EXPIRY DATE 11/2013.