BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TT BASIC HVLP TRACHEOSTOMY TUBE 7.8 MM

    MDR report key: 2993019 · Received March 1, 2013

    Report

    Report Number
    9611710-2013-00204
    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
    PMA / PMN Number
    K945874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). 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. 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 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. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). COMPLAINT RECEIVED AS FOLLOWS: MARKET COUNTRY: (B)(6). CUFF WAS LEAKING IN USE. NO HARM OR INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90887 TT BASIC HVLP TRACHEOSTOMY TUBE 7.8 MM TRACHEOSTOMY TUBE AND TUBE CUFF JOH UNOMEDICAL SDN BHD MM62525075 540174R002

    Patients

    Seq Age Sex Outcome Treatment
    1