BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ PULMONARY

    MDR report key: 7732637 · Received July 30, 2018

    Report

    Report Number
    3005099803-2018-02482
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Report Date
    July 1, 2018
    Product Code
    KTI
    PMA / PMN Number
    K023337
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 3 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012010, 1 COMPLAINT DEVICE WAS RETURNED AND 2 COMPLAINT DEVICES WERE NOT RETURNED. ONE EVENT WAS FOUND TO HAVE A ROOT CAUSE OF SUPPLIER DESIGN. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR "DEVICE NOT RETURNED" FOR ALL RELEVANT EVENTS.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012010 FOR PRODUCT CODE KTI. THIS REPORT COVERS 3 REPORTED EVENTS OF BALLOONS LEAKS/PINHOLES. OF THE EVENTS, 1 PATIENT WAS FEMALE. ONE PATIENT'S AGE WAS (B)(6). ONE PATIENT'S WEIGHT WAS (B)(6). ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573137 CRE¿ PULMONARY BRONCHOSCOPE ACCESSORY KTI M00550350

    Patients

    Seq Age Sex Outcome Treatment
    1