BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 1594299 · Received January 27, 2010

    Report

    Report Number
    2520313-2010-00004
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 27, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    FPK
    Removal / Correction Number
    2520313-1/15/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MPATS WERE DISCARDED BY THE CUSTOMER AND THEREFORE COULD NOT BE EVALUATED BY MEDRAD. THE SITE REPORTED THAT LOT NUMBER 820007 WAS IN-USE, WHICH IS CURRENTLY UNDER RECALL FOR FLASH IN ONE OF THE MOLDED PLASTIC COMPONENTS. ALTHOUGH WE ARE UNABLE TO CONFIRM THE PRESENCE OF FLASH WITHOUT RETURNED PRODUCT, IT IS POSSIBLE THAT THE DEVICE USED DURING THIS EVENT MAY HAVE CONTRIBUTED TO A MALFUNCTION, AS DEFINED IN 21 CFR 803. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY OBSERVED LOW FLOW OF SALINE DURING THE PURGE PROCESS THROUGH THREE DIFFERENT MULTI-PATIENT DISPOSABLE SETS (MPAT) FROM THE SAME LOT NUMBER. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET FPK MEDRAD, INC. 3018231 820007

    Patients

    Seq Age Sex Outcome Treatment
    1 AVANTA FLUID MANAGEMENT INJECTION SYSTEM