BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 3925378 · Received July 3, 2014

    Report

    Report Number
    2183502-2014-00460
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RETURNED AND EXAMINED. UPON PRESSURIZATION, THE CUFF WAS FOUND TO HAVE A SMALL TEAR LOCATED WHERE THE CUFF IS BONDED TO THE TUBE. ALL INFLATED AIR IMMEDIATELY ESCAPED THROUGH THE TEAR; THE CUFF WAS NOT ABLE TO BE INFLATED. MANUFACTURING DOES A 100% INFLATION TEST OF THE CUFFS AND HAD THE TEAR BEEN THERE AT THE TIME IT WOULD HAVE BEEN DETECTED AND SCRAPPED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE LISTED TRACHEOSTOMY TUBE WAS FOUND LEAKING AT THE CUFF IMMEDIATELY UPON USE. AN EXCHANGE OF THE TRACHEOSTOMY TUBE WAS REQUIRED. USER FACILITY REPORTED THE LEAKING WAS CAUSED BY A HOLE IN THE CUFF, WHICH WAS OBSERVED AFTER THE DEVICE REMOVAL. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389107 PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE BTO - TRACHESOTOMY TUBES BTO SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention