BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 468776 · Received June 24, 2003

    Report

    Report Number
    1423500-2003-00647
    Event Type
    Malfunction
    Date Received
    June 24, 2003
    Date of Event
    May 1, 2003
    Report Date
    May 25, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTS FOUR INCIDENTS OF TRANSFER SETS WITH BROKEN CLAMPS. NOTED DURING USE. THE TRANSFER SET WERE IN USE FOR APPROX THREE MONTHS. HTE PT INJURY OR MEDICAL INTERVENTION REPORTED PER BAXTER AFFILIATE.

    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 CORP. NA H02C21040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN