BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-TYPE ADMINISTRATION SET WITH SIDE ARM DRAINAGE TUBE

    MDR report key: 182593 · Received July 10, 1998

    Report

    Report Number
    1423500-1998-01509
    Event Type
    Malfunction
    Date Received
    July 10, 1998
    Date of Event
    June 10, 1998
    Report Date
    June 11, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED ONE INCIDENT OF TUBING LEAK NEAR THE Y-JUNCTION DURING INFUSION OF DIALYSIS SOLUTION. THE SET WAS CLAMPED AND REPLACED WITH A NEW SET TO CONTINUE TREATMENT. ACCORDING TO THE HEALTH CARE PROFESSIONAL THERE WAS NO MEDICAL INTERVENTION, NO PT INJURY AND THE SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE ADMINISTRATION SET WITH SIDE ARM DRAINAGE TUBE ADMINISTRATION SET FKX BAXTER HEALTHCARE CORP. NA U410654X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN