BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 10362547 · Received August 4, 2020

    Report

    Report Number
    3010617000-2020-00772
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    January 1, 2020
    Report Date
    August 4, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 16, 2020, ZOLL RECEIVED A MEDWATCH REPORT # (B)(4). THEREFORE, THIS SUBMISSION WAS CREATED TO RESPOND TO FDA. THE CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS DISCARDED BY THE CUSTOMER. SINCE THE DEVICE WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON JULY 16, 2020, ZOLL RECEIVED A MEDWATCH REPORT # (B)(4): "DURING INSERTION, THE DOCTOR MET RESISTANCE, THEN ABORTED THE INSERTION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE SHEATH WAS SEVERELY DAMAGED." NO FURTHER INFORMATION COULD BE RETRIEVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826417 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 89943 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1