BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 3252580 · Received July 15, 2013

    Report

    Report Number
    9616066-2013-00522
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CRACKED LUER. BAG CONTAINING IV SET GIVEN TO CFN SALES REP. NO DETAILED OR WRITTEN REPORT OF PT EVENT PROVIDED. NO PT HARM WAS REPORTED AND MEDICAL INTERVENTION WAS NOT REQUIRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327433 ALARIS EXTENSION SET FPA CAREFUSION CORP 30914 12085962

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA