BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 12520509 · Received September 23, 2021

    Report

    Report Number
    3012307300-2021-09564
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Report Date
    June 15, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    UDI-DI
    15019315042829
    PMA / PMN Number
    K040014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE GUIDE WIRE OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC WOULD KINK DURING PLACEMENT, MAKING IT VERY DIFFICULT TO PLACE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415431 PORTEX TRACHEOSTOMY TUBE AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/562/000 4067899 15019315042829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown