BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS NON-VENTED BLOOD SET

    MDR report key: 3012723 · Received March 8, 2013

    Report

    Report Number
    3012723
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    November 19, 2012
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION 303 INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    BLOOD TUBING TO BE IN 2 PIECES WHEN OPENED IN PACKAGE. STRETCHY PIECE WHICH IS PLACED IN IV PUMP WAS NOT CONNECTED TO THE LOWER PIECE OF BLOOD TUBING. TUBING NOT UTILIZED ON PATIENT.======================MANUFACTURER RESPONSE FOR ALARIS BLOOD TUBING, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================SET TO BE RETURNED TO MANUFACTURER FOR FAILURE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100407 ALARIS NON-VENTED BLOOD SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303 INC * LOT # BLANK ON PACKAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 *