BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC

    MDR report key: 2932258 · Received January 18, 2013

    Report

    Report Number
    MW5028721
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CHEMOTHERAPY (5-FLUOROURACIL) LEAK FROM NEEDLE. DATES OF USE: 46 HOURS (B)(6) 2013. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. DIAGNOSIS OR REASON FOR USE: COLORECTAL CANCER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28537 MINILOC NONE FPA BARD ACCESS SYSTEMS, INC. 2015-09 ASWIS244

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR