BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2958101 · Received February 6, 2013

    Report

    Report Number
    9611710-2013-00075
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    June 15, 2012
    Report Date
    June 15, 2012
    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

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS ISSUE IS DEEMED A SERIOUS MALFUNCTION BECAUSE '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. THE DEVICE WAS NOT RETURNED TO THE MFR BUT WAS EVALUATED BY KCC WHO CONFIRMED THAT THE MATERIAL INSIDE THE TUBE WAS NOT INDUCED DURING THE EXTRUSION PROCESS. THEY FOUND NO EVIDENCE THAT THE MATERIAL WAS PLASTIC OR SYNTHETIC POLYMER. THE MATERIAL RECOVERED FROM THE INTERIOR GAVE A POSITIVE BLUE STAIN RESULT FOR ALBUMIN PROTEINS TESTING, AS DID THE CONTROL SAMPLE OF SKIN. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED BY (B)(4) ON (B)(4) 2012 FROM (B)(6) FOR PRODUCT ENDOTRACHEAL TUBE SIZE 8.0MM. CUSTOMER COMPLAINING: "WHEN PERFORMING A BEDSIDE TRACH, DR RUMBER NOTICED WHAT LOOKED LIKE PLASTIC PEELING OFF THE INSIDE OF THE TUBE. THE INCIDENT OCCURRED WHEN PERFORMING A PERC TRACH BEDSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49790 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 35216 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening