BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT ACCESS TRAY

    MDR report key: 10270148 · Received July 13, 2020

    Report

    Report Number
    MW5095504
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 10, 2020
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OKE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732936 PORT ACCESS TRAY PORT INTRODUCER KIT OKE MEDLINE INDUSTRIES, INC. 2OBBW183
    732937 PORT ACCESS TRAY PORT INTRODUCER KIT OKE MEDLINE INDUSTRIES, INC. 2OBBW183

    Patients

    Seq Age Sex Outcome Treatment
    1