BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2945120 · Received January 31, 2013

    Report

    Report Number
    9611710-2013-00058
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). THIS IS RELATED TO (FDA AUDIT-OBSERVATION (B)(4)). BASED ON AVAILABLE INFO, THIS ISSUE IS DEEMED A SERIOUS MALFUNCTION BECAUSE AN 'INNER TUBE DELAMINATION' 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 (B)(4)). THIS COMPLAINT WAS REC'D BY (B)(4) ON (B)(6) 2012 FROM (B)(4) FOR PRODUCT REINFORCED TUBE SIZE 7.5MM. CUSTOMER COMPLAINING: " FUNCTIONAL FAILURE - (INNER LAYER DELAMINATION)" .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43506 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 66D1487 610542R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening