BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 13090665 · Received December 27, 2021

    Report

    Report Number
    1417592-2021-00230
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    December 20, 2021
    Report Date
    December 27, 2021
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    MCY
    UDI-DI
    10889942117291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A MALE UNDERGOING A COMPUTERIZED TOMOGRAPHY (CT) SCAN HAD A DEVICE PLACED IN THE RIGHT ANTECUBITAL (A/C) FOSSA. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND UPON WALKING INTO THE ROOM TO BEGIN INJECTION OF CONTRAST MATERIAL THE TECH NOTICED THAT THE HUB THAT SHOULD HAVE BEEN SEALED HAD COME UNDONE WHILE THE TECH WAS IN THE CONTROL ROOM SETTING UP FOR THE EXAM. THE PATIENT BLED ON THE TABLE AND THE FLOOR (TOTAL AMOUNT OF BLOOD LOSS UNKNOWN). THE TECH WAS ABLE TO CLEAN UP THE PATIENT, PLACE A NEW CATHETER AND COMPLETE THE PROCEDURE AS ORDERED WITHOUT FURTHER INCIDENT. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB CAME UNDONE WHILE CONNECTED TO THE PATIENT PRIOR TO STARTING THE CONTRAST AND THE PATIENT BLED ON THE TABLE AND THE FLOOR (TOTAL AMOUNT OF BLOOD LOSS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984842 Medline Industries, Inc. IV START KIT MCY MEDLINE INDUSTRIES, LP DYNDV1938 21HBH646 10889942117291

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention