MalfunctionOKE
TRAY, PORT-A-CATH ACCESS
Received May 7, 2018 · Event occurred Mar 29, 2018
Report MW5077069 · MDR key 7494303
Device
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
9 YR
- No Information
- No Information
Narrative
Description of Event or Problem
OPENED A "STERILE" PORT A CATH ACCESS TRAY AND PLACED ITEMS ON A STERILE FIELD USING STERILE TECHNIQUE. UPON INSPECTION, PACKAGE WAS NOTED TO HAVE A HOLE IN THE MIDDLE OF THE STERILE FIELD NEXT TO THE TRAY. REPLACED THE TRAY AND ENTIRE CONTENTS.