BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2945119 · Received January 31, 2013

    Report

    Report Number
    9611710-2013-00057
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    November 30, 2011
    Report Date
    November 30, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO (FDA (B)(4)). BASED ON AVAILABLE INFO, THIS ISSUE IS DEEMED A SERIOUS MALFUNCTION BECAUSE INNER TUBE DIAMETER NARROWING EXPOSES THE PT TO THE POSSIBILITY THAT A BRONCHOSCOPE OR SUCTION CATHETER COULD BECOME 'STUCK' IN THE ENDOTRACHEAL TUBE PUTTING THE PT AT THE RISK OF ALVEOLI COLLAPSE AND/OR OXYGEN DESATURATION WITH PT HAVING TO UNDERGO RE-INTUBATION. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT,) IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS REC'D ON (B)(6) 2011, FROM MEDTRONIC INC USA FOR PRODUCT REINFORCED TUBE SIZE 8.5MM. CUSTOMER COMPLAINING: " DIM FAILURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42619 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 66D1495 608777R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening