inforMED
MalfunctionOGD

EP PACK

Received Oct 10, 2016 · Event occurred Oct 7, 2016

Report MW5065352 · MDR key 6025422

Device

Generic name

Custom Anesthesia Tray

Manufacturer

Avid

Model number

ADVH086-05

Product problems

  • Device Contamination with Chemical or Other Material

Patient

59 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

WHEN THE STERILE PACK WAS OPENED FOR THE PROCEDURE, A FOREIGN OBJECT WAS FOUND IN THE STERILE FIELD (CLIP WITH THREE PAPER DISKS). THE TRAY WAS DISCARDED. NO HARM TO PT.