BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASPAN

    MDR report key: 923182 · Received September 9, 2007

    Report

    Report Number
    3003568924-2007-00005
    Event Type
    Malfunction
    Date Received
    September 9, 2007
    Report Date
    September 26, 2007
    Manufacturer
    BARR LABS
    Product Code
    KDL
    PMA / PMN Number
    K944866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    CASE DESCRIPTION: INFORMATION WAS RECEIVED REGARDING A BAG OF VIASPAN SOLUTION (LOT NUMBER H050027, EXP. 05/08) THAT WAS LEAKING. THE REPORTER STATED THAT BETWEEN THE INNER AND OUTER BAGS THERE IS APPROXIMATELY ONE HALF LITER OF LIQUID. THE REPORTER STATED THAT THE INNER BAG OF VIASPAN APPEARS TO BE SMALLER IN SIZE, AND HE FEELS THAT IT IS THE VIASPAN SOLUTION THAT IS LEAKING OUT. THE REPORTER ALSO MENTIONED THAT THIS HAPPENED LAST WEEK WITH ANOTHER BAG OF VIASPAN (UNKNOWN LOT NUMBER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASPAN COLD STORAGE SOLUTION (BELZER UW) KDL BARR LABS UNK H050027

    Patients

    Seq Age Sex Outcome Treatment
    1 YR