BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 3173182 · Received June 5, 2013

    Report

    Report Number
    9616066-2013-00437
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790582
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 SET LEAKING FROM A 0.5 INCH SPLIT AT MALE LUER END OF THE SET DURING INFUSION. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249623 ALARIS SECONDARY SET FPA CAREFUSION CORPORATION 72213N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK