inforMED
MalfunctionPXK

PRESOURCE PICC TRAY KITS

Received May 1, 2025

Report MW5169734 · MDR key 21944115

Device

Generic name

Vascular Access Port Kit

Model number

(20-8425B)

Lot number

457423

Product problems

  • Delivered as Unsterile Product
  • Packaging Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

STERILE GLOVES IN THE PERIPHERALLY INSERTED CENTRAL CATHETER TRAY KITS ARE FOLDED IN THE STERILE PAPER, BUT UNLIKE THE PORT KITS, THE PAPER & GLOVES ARE NOT INSIDE THE SEALED PLASTIC WRAP. THE NURSE STATES SHE WAS UNABLE TO FIND AN EXPIRATION DATE ON THE GLOVE PAPER PACKAGE.