BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY IV SET

    MDR report key: 6085557 · Received November 3, 2016

    Report

    Report Number
    MW5065875
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    UNK
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT IN CLINIC FOR CHEMOTHERAPY. TWENTY MINUTES AFTER THE TREATING RN STARTED THE INFUSION, SHE NOTED THAT THE IV TUBING WAS LEAKING AROUND THE TERMINAL END. DIAGNOSIS OR REASON FOR USE: BREAST CA. WE HAVE THREE LOTS OF THIS IV TUBING ON SITE AND WE ARE UNABLE TO DETERMINE WHICH WAS USED. THE ENTIRE TUBE AND IV BAG WERE CONTAMINATED WITH CHEMOTHERAPY AND WE CANNOT SEND IN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728819 SECONDARY IV SET SECONDARY IV SET FPA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INTRAVENOUS