BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTENDED LIFE PD TRANSFER SET (EASY-LOCK)

    MDR report key: 648542 · Received November 29, 2005

    Report

    Report Number
    1423500-2005-01934
    Event Type
    Malfunction
    Date Received
    November 29, 2005
    Date of Event
    August 31, 2005
    Report Date
    November 20, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED THAT A PATIENT NEEDED TO REPLACE THE TRANSFER SET BECAUSE THE BLUE CONNECTOR WAS BROKEN DURING USE. THE SET WAS PLACED IN 2005 (17 DAYS). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED ACCORDING TO BAXTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTENDED LIFE PD TRANSFER SET (EASY-LOCK) TRANSFER SET KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN