BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 13513682 · Received February 11, 2022

    Report

    Report Number
    13513682
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 7, 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

    PATIENT ARRIVED FOR INFUSION THERAPY. WHEN PREPPING FOR INFUSION, THE MEDLINE PORT ACCESS KIT SAFETY SHIELD WAS ALREADY PULLED OVER THE NEEDLE PRIOR TO THE PACKAGE BEING OPENED. COSTLY PRODUCT NOT ABLE TO BE USED. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WILL INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74528 MEDLINE INDUSTRIES, INC. GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNDC2409A 2021110390 10889942805693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown