BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (55) KIT STC TRACHEOSTOMY TOTE

    MDR report key: 18181113 · Received November 21, 2023

    Report

    Report Number
    18181113
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    August 28, 2023
    Report Date
    November 15, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NXA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IN THE MEDLINE STC TRACHEOSTOMY TOTE, THE CATHETER SUCTION AND THE ID BAND ON THE CONTENTS SHEET SHOULD ONLY BE LOCATED IN THE TRACHEOSTOMY BUNDLE, WHICH IS MISSING FROM THE TRACHEOSTOMY KIT. THESE ARE CRUCIAL. MISCELLANEOUS BUNDLE SEPARATE FOR A REASON TO ADD TRACHS TO AND SEND WITH THE PATIENT TO HAVE IN CASE OF AIRWAY OBSTRUCTION OR OTHER AIRWAY EMERGENCIES. SO, THESE ITEMS SHOULD BE PACKAGED ALL IN ONE TO IDENTIFY WHAT KIND OF TRACH, WHAT INCISION TYPE, AND WHO THE SURGICAL TEAM TAKING CARE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089703 (55) KIT STC TRACHEOSTOMY TOTE TRACHEOTOMY CARE KIT NXA MEDLINE INDUSTRIES, INC. DYNJ909525 23EBJ496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown