BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 12049339 · Received June 23, 2021

    Report

    Report Number
    3012307300-2021-06433
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 23, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC MALFUNCTIONED. REPORTED WHEN PLACING THE TRACHEOSTOMY AND FILLING THE PNEUMOTAPONER (THE PRESSURE CONTROL FILLING METER), EVIDENCE SHOWED THE BALL IS BROKEN. ITEM WAS REPLACED, NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946800 PORTEX PDT ULTRAPERC JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/563/080 4056530

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR