BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10379372 · Received August 7, 2020

    Report

    Report Number
    3012307300-2020-07935
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 1, 2020
    Report Date
    September 23, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315038808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE USED SAMPLE WAS RETURNED FOR EVALUATION P/N 100/870/080 WITH LOT NUMBER REPORTED UNKNOWN; THE SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING. NO WATER WAS FOUND IN THE PILOT BALLOON OR CUFF OF THE RETURNED SAMPLE. NO DISCREPANCIES WERE FOUND IN THE RETURNED SAMPLE DURING FUNCTIONAL TESTING. NO FAULT WAS FOUND WITH THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF COMPONENT OF THE PORTEX TRACHEOSTOMY TUBE EASILY DEFLATED DURING USE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841896 PORTEX TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/870/080 15019315038808

    Patients

    Seq Age Sex Outcome Treatment
    1