BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EUROPE (CE LABEL)

    MDR report key: 1122323 · Received August 15, 2008

    Report

    Report Number
    1423500-2008-00749
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED A MINICAP DISCONNECT CAP 'KEPT FALLING OFF' OF THE PATIENT'S TRANSFER SET. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EUROPE (CE LABEL) DISCONNECT CAP / 78KDJ KDJ BAXTER HEALTHCARE CORPORATION 07J25H15

    Patients

    Seq Age Sex Outcome Treatment
    1