BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER

    MDR report key: 2163472 · Received July 7, 2011

    Report

    Report Number
    1066369-2011-00001
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LEVENTON S.A.U.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOOKED ON (B)(6) 2011 AND IT WAS FOUND ON (B)(6) 2011 THAT THERE WAS LEAKAGE IN THE CAPSULE. THE BALLOON DID NOT BURST BUT THERE WAS LIQUID INSIDE THE CAPSULE AND THERE WAS WHITE 5-FU (5-FLOUROURACIL) CRYSTALLIZATION FORMED AROUND THE RIM. IT LEAKED OUTSIDE INTO THE BAG AND ON TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOSI-FUSER ELASTOMERIC INFUSION PUMP MEB LEVENTON S.A.U. L25915-250D5-USA 101643L

    Patients

    Seq Age Sex Outcome Treatment
    1