BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE- AIRWAY MANAGEMENT

    MDR report key: 2971392 · Received February 4, 2013

    Report

    Report Number
    9611710-2013-00064
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 13, 2012
    Report Date
    February 17, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF PRIVATE LABEL COMPLAINTS FROM OUR FACILITY IN MALAYSIA. THIS IS RELATED TO (FDA AUDIT-OBSERVATION #7 FROM (B)(4)). BASED ON THE AVAILABLE INFORMATION, THIS ISSUE IS DEEMED A SERIOUS MALFUNCTION BECAUSE OF THE POSSIBILITY THAT A BRONCHOSCOPE OR SUCTION CATHETER COULD BECOME 'STUCK' IN THE ENDOTRACHEAL TUBE PUTTING THE PATIENT AT THE RISK OF ALVEOLI COLLAPSE AND/OR OXYGEN DESATURATION WITH PATIENT HAVING TO UNDERGO RE-INTUBATION. REPORTED TO THE FDA ON (B)(6) 2013.

    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 RECEIVED BY (B)(6) 2012, (B)(46) FOR PRODUCT REINFORCED TUBE SIZE 7.0MM. CUSTOMER COMPLAINING: "THERE WAS A BUMP INSIDE OF THE TUBE AT THE PROXIMAL (MACHINE) END. THEREFORE, A SUCTION TUBE WAS ABLE TO PASS THROUGH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47533 ENDOTRACHEAL TUBE- AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 61214070IJ 609064R002

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening