BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 21159052 · Received January 15, 2025

    Report

    Report Number
    21159052
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 23, 2024
    Report Date
    January 6, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    NEEDLE NOSE HEMOSTATS BROKE WHILE RADIOLOGIST WAS TRYING TO USE THEM. THESE HEMOSTATS WERE IN THE MINOR RADIOLOGY PACK SOURCED FROM MEDLINE. MANUFACTURER RESPONSE FOR CARDIAC CATHETERIZATION KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WAITING FOR VENDOR TO COMPLETE THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583556 MEDLINE INDUSTRIES, INC. CARDIAC CATHETERIZATION KIT OES MEDLINE INDUSTRIES, INC. DYNJ62860C 24HMC359

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male