BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SPINAL BLOCK TRAY 25G WHITACRE

    MDR report key: 18595400 · Received January 29, 2024

    Report

    Report Number
    18595400
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    August 24, 2023
    Report Date
    September 20, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HERE FOR SCHEDULED INDUCTION OF LABOR. SHE WAS SITTING UP TO RECEIVE SPINAL ANESTHESIA. WHILE NEEDLE WAS BEING INSERTED BY ANESTHESIA PROVIDER, THE SPINAL NEEDLE BROKE OFF WITHIN THE PATIENT'S BACK WHEN THE NEEDLE DETACHED FROM THE NUB. THE NEEDLE REMAINED IN THE PATIENT'S BACK. ANESTHESIA PROVIDER WAS ABLE TO REMOVE THE NEEDLE SAFELY. NO APPARENT HARM TO PATIENT. COMPANY REPRESENTATIVE WAS NOTIFIED AT THE TIME OF THE EVENT, AND THE REMAINING SUPPLIES OF THIS TYPE WERE REMOVED FROM THE SUPPLY AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649423 MEDLINE SPINAL BLOCK TRAY 25G WHITACRE GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNJRA9032 23EBG306

    Patients

    Seq Age Sex Outcome Treatment
    1 6935 DA Female