BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY, PORT-A-CATH ACCESS

    MDR report key: 7494303 · Received May 7, 2018

    Report

    Report Number
    MW5077069
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    March 29, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDLINE
    Product Code
    OKE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332163 TRAY, PORT-A-CATH ACCESS TRAY, PORT-A-CATH ACCESS OKE MEDLINE 17LB9811

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR