BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET

    MDR report key: 176715 · Received July 7, 1998

    Report

    Report Number
    1423500-1998-01501
    Event Type
    Malfunction
    Date Received
    July 7, 1998
    Date of Event
    April 30, 1998
    Report Date
    May 6, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED LEAK IN DRAIN BAG OF Y-SET DURING USE. NO PATIENT INJURY WAS REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET ULTRA SET KDJ BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 *