BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 638381 · Received August 24, 2005

    Report

    Report Number
    1423500-2005-01363
    Event Type
    Malfunction
    Date Received
    August 24, 2005
    Date of Event
    July 22, 2005
    Report Date
    July 27, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTS, "A PT NEEDED TO REPLACE THE TRANSFER SET, BECAUSE THE OCCLUDER FEET ARE BROKEN. LEAKS CAN BE OBSERVED WHEN THE MINI CAP IS REMOVED. THE REPORTED SET WAS PLACE IN 05/2005." THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT ACCORDING TO BAXTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR