BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 16033384 · Received December 22, 2022

    Report

    Report Number
    16033384
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 6, 2022
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    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

    LOCATION: INFUSION THERAPY PROCEDURE: INFUSION ISSUE; WHEN THE PORT KIT WAS OPENED, THE SAFETY OVER THE NEEDLE WAS ALREADY ACTIVATED PRIOR TO USE. NEW ONE OBTAINED AND USED WITHOUT FURTHER ISSUE. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612817 MEDLINE INDUSTRIES, INC. GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNDC2409A 2022050990

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown