BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10755341 · Received October 29, 2020

    Report

    Report Number
    3012307300-2020-10771
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    July 28, 2020
    Report Date
    December 7, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS BREATHING/PORTEX GENERAL ANESTHESIA GAS SAMPLING SAMPLE AND PICTURES RECEIVED. SAMPLE N 225-3422-800, L/N 3942826; THE SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING. WHEN VISUALLY INSPECTING DEVICE FROM 12" -16 ? EXCESSIVE SOLVENT WAS FOUND IN THE TUBE. THIS COMPLAINT WAS VERIFIED AND QUALITY REVIEW TO ADDRESS.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND FOUND TO LEAK. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224621 PORTEX BTO SMITHS MEDICAL INTERNATIONAL, LTD. 225-3422-800 3942826

    Patients

    Seq Age Sex Outcome Treatment
    1