BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TT BASIC HVLP TRACHEOSTOMY TUBE 6.0 MM

    MDR report key: 3032960 · Received April 1, 2013

    Report

    Report Number
    9611710-2013-00236
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 5, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K945874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, MEDICAL DETERMINATION IS THAT THIS IS A SERIOUS MALFUNCTION. A LEAKING ENDOTRACHEAL/TRACHEOSTOMY TUBE CUFF EXPOSES THE PATIENT TO THE RISK OF ASPIRATION OF GASTRIC CONTENTS AND A REDUCTION IN VENTILATION PRESSURE. ALTHOUGH THERE IS A POTENTIAL FOR A SERIOUS INJURY, THE LIKELIHOOD OF SUCH AN OCCURRENCE IS LOW BECAUSE THESE DEVICES UNDERGO RIGOROUS TESTING AND ARE ONLY USED IN HIGHLY MONITORED AND HIGHLY SPECIALIZED SETTINGS. A LEAKING CUFF WOULD LIKELY TRIGGER ALARMS TO ALERT CARE-GIVERS AND IN MOST CASES ALL THAT IS REQUIRED IS A SIMPLE RE-INFLATION BY THE BEDSIDE. HOWEVER, IN SOME CASES OF A RAPID LEAK, THE PATIENT MAY REQUIRE A COMPLETE RE-INTUBATION. THIS PROCEDURE, IF CARRIED OUT IN EXPERT, EXPERIENCED HANDS, HAS A LOW INCIDENCE OF SERIOUS COMPLICATIONS. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "MARKET COUNTRY: (B)(6). COMPLAINT DESCRIPTION: THE CUFF LEAKAGE WAS NOTED IN USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132601 TT BASIC HVLP TRACHEOSTOMY TUBE 6.0 MM TRACHEOSTOMY TUBE AND TUBE CUFF BTR UNOMEDICAL SDN BHD MM62525060 541335R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention