BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 7.0MM CUFFED TRACHEAL TUBES

    MDR report key: 2881209 · Received November 14, 2012

    Report

    Report Number
    2183502-2012-00549
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SAMPLE WAS RECEIVED FOR EVAL. UPON PRESSURIZATION, THE CUFF WAS FOUND TO LEAK. VISUAL INSPECTION OF THE CUFF FOUND A CUT AND A CLEAR SUBSTANCE WAS OBSERVED ON THE CHECK VALVE ASSEMBLY. MANUFACTURING DOES A 100% INFLATION TEST OF THE CUFF AND HAD THE DAMAGE BEEN THERE AT THAT TIME, IT WOULD HAVE BEEN DETECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNK AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX 7.0MM CUFFED TRACHEAL TUBES ENDOTRACHEAL TUBES JOH SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK