BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURE FLOW

    MDR report key: 2507739 · Received March 27, 2012

    Report

    Report Number
    3002843564-2011-00002
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    May 10, 2011
    Report Date
    May 19, 2011
    Manufacturer
    WOO YOUNG MEDICAL INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VICTUS RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2010 REPORTING THAT 46 HOURS AFTER INITIATING INFUSION OF 5FU, THE CHEMOTHERAPY DRUG BEGAN LEAKING AT THE POINT WHERE THE SECURE-FLOW DEVICE ATTACHES TO THE INJECTION CAP AT THE PORT LINE (MFG BY ANOTHER MFR). NOTE: THE VICTUS SECURE-FLOW DEVICE IS MFG BY (B)(4) AND WAS CLEARED AS ACCUFUSER UNDER 510(K) NUMBER K003915. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE FLOW ELASTOMERIC INFUSION PUMP KIT MEB WOO YOUNG MEDICAL INC. NA CDHKP184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA