BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    READYMED ELASTOMERIC INFUSION SYSTEM

    MDR report key: 1339576 · Received January 7, 2009

    Report

    Report Number
    9616066-2009-00009
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Report Date
    December 9, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    MEB
    PMA / PMN Number
    K913658
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    EVENT OCCURRED IN 2008. CUSTOMER REPORTED LEAKING FROM THE READYMED. THE USER FILLED THE READYMED DEVICE WITH NORMAL SALINE, PLACED IT IN A ZIP LOCK BAG AND STORED IT IN THE REFRIGERATOR UNTIL READY TO USE. WHEN READY TO USE THE DEVICE AND ADD THE MEDICATION, OBSERVED FLUID LEAKING FROM THE AREA WHERE THE BLADDER AND THE PLASTIC HOUSING OF THE DEVICE MEET. NO PT CONTACT, NO PT HARM REPORTED AND NO OTHER EVENT DETAILS AVAILABLE. PRODUCT WAS REQUESTED BUT NOT RECEIVED TO DATE. A FOLLOW UP REPORT WILL BE FILED IF PRODUCT IS RECEIVED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 READYMED ELASTOMERIC INFUSION SYSTEM MEB CARDINAL HEALTH ALARIS PRODUCTS R250167 08085567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK