BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTRACKER-18

    MDR report key: 175960 · Received June 30, 1998

    Report

    Report Number
    6000078-1998-00080
    Event Type
    Malfunction
    Date Received
    June 30, 1998
    Report Date
    June 30, 1998
    Manufacturer
    TARGET THERAPEUTICS/A BOSTON SCIENTIFIC CO
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT WAS RETURNED TO TARGET WITH NO COMPLAINT INFORMATION. HOWEVER, DURING INSPECTION ON 06/03/1998, IT WAS DISCOVERED THAT THE PRODUCT HAD RUPTURED, THUS MAKING THIS A MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTRACKER-18 INFUSION CATHETER DQO TARGET THERAPEUTICS/A BOSTON SCIENTIFIC CO NA A61617

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO