BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 13688732 · Received March 8, 2022

    Report

    Report Number
    3012307300-2022-04372
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 1, 2022
    Report Date
    May 4, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019517076134
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNABLE TO BE EVALUATED AS IT WAS NOT RETURNED. IF THE DEVICE IS RECEIVED IN THE FUTURE AN EVALUATION WILL BE PERFORMED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. A DHR REVIEW WAS UNABLE TO BE COMPLETED AS NO LOT INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. THE PROBLEM SOURCE IS UNKNOWN. SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED THEREFORE INTERNAL NON-CONFORMITY REPORT NCR-000928 WAS CREATED WITH PURPOSE TO EVALUATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, IMMEDIATELY UPON USE, THE INFLATION LINE WAS DETACHED FROM THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168165 PORTEX TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 101/860/070CZ 15019517076134

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown