BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE PEDIATRIC, SIZE 3.0 MM

    MDR report key: 4152505 · Received October 6, 2014

    Report

    Report Number
    9611710-2014-00289
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS FURTHER REPORTED THAT A FACILITY MEDICAL PRACTITIONER DESCRIBED THE PARTICULAR AREA ON THE ADAPTER AS VERY THIN. THE PRODUCT WAS DIAGNOSTICALLY IN USE AT THE TIME OF THE EVENT. BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE USER FACILITY OBSERVED THREE (3) PRODUCT ADAPTERS WERE BROKEN DURING ADAPTER EXCHANGE FOR CO2 MEASUREMENT AND/OR WHEN DISCONNECTED FOR SUCTIONING. THE BREAKAGE WAS DESCRIBED AS A "CONNECTOR DETACHMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622172 ENDOTRACHEAL TUBE PEDIATRIC, SIZE 3.0 MM TUBE, RACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35111 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1