BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP

    MDR report key: 598018 · Received April 27, 2005

    Report

    Report Number
    1423500-2005-00586
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    April 17, 2005
    Report Date
    April 18, 2005
    Manufacturer
    MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NATIONAL COMPLAINT COORDINATOR OF BAXTER REPORTS A HOME PATIENT HAS SOLUTION LEAK FROM THE TIP OF THE TRANSFER SET WHEN PATIENT CLOSED THE INTEGRAL TWIST CLAMP TO DISCONNECT DURING EXCHANGE. A SAMPLE IS AVAILABLE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP TRANSFER SET KDJ MOUNTAIN HOME NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN