BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TT BASIC HVLP TRACHEOSTOMY TUBE 7.5 MM

    MDR report key: 3032941 · Received April 1, 2013

    Report

    Report Number
    9611710-2013-00235
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 5, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    JOH
    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. AN ANALYSIS ON THE RETURNED SAMPLES PROVIDED WAS TESTED AND DID NOT PERFORM TO OUR REQUIREMENT. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "COMPLAINT DESCRIPTION: THE CUFF LEAKAGE WAS NOTED IN USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133250 TT BASIC HVLP TRACHEOSTOMY TUBE 7.5 MM TRACHEOSTOMY TUBE AND TUBE CUFF JOH UNOMEDICAL SDN BHD MM62525075 541752R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R