BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11280134 · Received February 4, 2021

    Report

    Report Number
    3012307300-2021-00853
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Report Date
    February 4, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315052644
    PMA / PMN Number
    K030381
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE LABEL FOR INNER CANNULA SHOWS ID IS 9.0 MM BUT ALSO SHOWS ID IS 8.0 MM. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176555 PORTEX INNER CANNULA BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/856/090 3921292 15019315052644

    Patients

    Seq Age Sex Outcome Treatment
    1