BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2998985 · Received February 21, 2013

    Report

    Report Number
    9611710-2013-00137
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS; "FACILITY HAS HAD AN ISSUE WHERE THE CUFF OF THE ET TUBE HAS BURST AND PT HAD TO BE REINTUBATED." THE EVAL WAS CONDUCTED BY CUSTOMER KCC, FOUND THE CUFF HAD BUST RADIALLY, CERTALLY BETWEEN THE PROXIMAL AND DISTAL CUFF COLLARS. CAUSE OF THE BURST WAS NOT PROVIDED TO DETERMINED. BASED ON AVAILABLE INFO, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE THE REPORT MENTIONED THAT THE PT REQUIRED RE-INTUBATION PULLED PT AT RISK FOR COMPLICATIONS. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75289 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 35216 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention