BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TT BASIC HVLP TRACHEOSTOMY TUBE 7.5 MM

    MDR report key: 2993037 · Received March 1, 2013

    Report

    Report Number
    9611710-2013-00205
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    July 27, 2012
    Report Date
    August 8, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, 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. HOWEVER, NO ADVERSE EVENT OCCURRED IN THIS CASE. WHILST THERE IS A RISK FOR SERIOUS INJURY FROM THIS MALFUNCTION, THE LIKELIHOOD OF 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 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 MARCH 1, 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). COMPLAINT RECEIVED AS FOLLOWS: MARKET COUNTRY: (B)(6). COMPLAINT DESCRIPTION: CUFF WAS LEAKING IN USE NO HARM OR INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89154 TT BASIC HVLP TRACHEOSTOMY TUBE 7.5 MM TRACHEOSTOMY TUBE AND TUBE CUFF JOH UNOMEDICAL SDN BHD MM6255075 540174R004

    Patients

    Seq Age Sex Outcome Treatment
    1