BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FLEXI-SET CUFFED 7.5MM

    MDR report key: 3972831 · Received April 28, 2014

    Report

    Report Number
    8040412-2014-00086
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 31, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. THE INFO CONTAINED IN THS MDR WAS OBTAINED FROM THE MAUDE REPORT. THE MAUDE REPORT DID NOT PROVIDE USER FACILITY INFO.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED VIA THE MAUDE REPORT AS: LIVER TRANSPLANT CASE. ROUTINE INTUBATION WITH ENDOTRACHEAL TUBE THAT WAS NEW TO OUR HOSPITAL (FLEXI-SET CUFFED ENDOTRACHEAL TUBE) BY RUSCH/TELEFLEX. NO PROBLEMS FOR ABOUT AN HOUR, THEN NOTED ETCO2 AND PEAK AIRWAY PRESSURES WERE GOING UP WITH 02 SATURATION AT 100%. THE IMPRESSION WAS THAT THE TUBE WAS PARTIALLY KINKED, BUT NO KINK WAS VISIBLE OUTSIDE OF THE PT OR WITHIN PALPABLE REACH INSIDE OF ORAL-PHARYNX. ATTEMPTED TO PASS BRONCHOSCOPE AND VISUALIZED KINKED ENDOTRACHEAL TUBE WITH KINK CLEARLY VISIBLE ABOVE THE VOCAL CORDS. GLIDESCOPE PASSED; TUBE WAS THROUGH THE VOCAL CORDS, KINK AT ALMOST 180 DEGREES ABOVE CORDS. THE ET TUBE WAS WITHDRAWN WITH PALPABLE SNAP AS TUBE UNKINKED. VENTILATION THEN EASY WITH LOW PRESSURE AND THE CASE PROCEEDED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253607 RUSCH FLEXI-SET CUFFED 7.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1