BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE PICC TRAY KITS

    MDR report key: 21944115 · Received May 1, 2025

    Report

    Report Number
    MW5169734
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    April 25, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    PXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071510 PRESOURCE PICC TRAY KITS VASCULAR ACCESS PORT KIT PXK CARDINAL HEALTH 200, LLC (20-8425B) 457423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown