BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEGEN ADMINISTRATION SET

    MDR report key: 3060005 · Received March 19, 2013

    Report

    Report Number
    9616066-2013-00192
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLUID LEAKED DURING AN INFUSION AT THE TUBING TO FILTER ENGAGEMENT. END USER: (B)(6). THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113125 MEDEGEN ADMINISTRATION SET FPA CAREFUSION CORP MX9411 12125369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK