BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 15454634 · Received September 20, 2022

    Report

    Report Number
    15454634
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 26, 2022
    Report Date
    August 26, 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

    MID 30¿S FEMALE WITH HISTORY OF BREAST CANCER. PROCEDURE: INFUSION TREATMENT. WHEN THE KIT WAS OPENED, THE HUBER NEEDLE WAS WITHOUT A PLASTIC SHEATH AND PARTIAL SAFETY CLIP CLOSURE. NOT USED ON PATIENT. THIS IS THE 4TH REPORT FOR NONACCEPTABLE NEEDLE. 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
    2660913 MEDLINE INDUSTRIES, INC. GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNDC2409A 2022041290 10889942805693

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA Female