inforMED
MalfunctionOKE

PORT ACCESS TRAY

Received Jul 13, 2020 · Event occurred Jul 9, 2020

Report MW5095504 · MDR key 10270148

Device

Generic name

Port Introducer Kit

Lot number

2OBBW183

Product problems

  • Detachment of Device or Device Component

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

GREEN CAP ON PORT ACCESS KIT COMES OFF OF CAP TIP. I HAVE TWO IN MY OFFICE FOR EVALUATION. SAME LOT NUMBER. FDA SAFETY REPORT ID# (B)(4).