BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE DIALYSIS TUBING

    MDR report key: 6025433 · Received October 10, 2016

    Report

    Report Number
    MW5065358
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 10, 2016
    Manufacturer
    NXSTAGE
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MALE PORTION OF TUBING CONNECTOR BROKE-OFF INSIDE THE PORT/CONNECTION OF A QUINTEN CATHETER. QUINTEN CATHETER WAS CLAMPED, DISCONTINUED AND RE-SITED. DIAGNOSIS OR REASON FOR USE: ACUTE RENAL FAILURE. EVENT ABATED AFTER USE, STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667065 NXSTAGE DIALYSIS TUBING NXSTAGE DIALYSIS TUBING KDI NXSTAGE 60778014

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other