BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11580220 · Received March 28, 2021

    Report

    Report Number
    3012307300-2021-02563
    Event Type
    Malfunction
    Date Received
    March 28, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 29, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC INVESTIGATION REVEALED NO PACKAGE WAS RECEIVED AT THE CUMBERNAULD SITE ON MAY 25TH, 2021 WITH CERTIFICATE OF SAFE HANDLING. WITH NO PACKAGING IT WAS REPORTED NOT ABLE TO ESTABLISH WHICH COMPONENTS HAD BEN USED IN THE PROCEDURE OF THE COMPLAINT.

    Description of Event or Problem · 1

    THE WHITE INTRODUCER OF THE DILATOR GETS STUCK IN THE PURPLE INTRODUCER. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477666 PORTEX TRACHEOSTOMY TUBE JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/561/090 4036724

    Patients

    Seq Age Sex Outcome Treatment
    1