BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 15470117 · Received September 23, 2022

    Report

    Report Number
    15470117
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 6, 2022
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    10889942805693
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INFUSION THERAPY: WHEN REMOVING THE MEDLINE, PORT ACCESS FROM PACKAGING, THE PROTECTIVE WINGS WERE ALREADY OVER THE NEEDLE. NOT USED ON PATIENT. REP - CHRIS HALL PICKED UP THE PRODUCT. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). OBTAINED AND WILL INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777046 MEDLINE INDUSTRIES, INC. GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNDC2409A 2022050990 10889942805693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown