BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-BAG PLUS

    MDR report key: 813361 · Received February 1, 2007

    Report

    Report Number
    MW1041836
    Event Type
    Malfunction
    Date Received
    February 1, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 1, 2007
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MINI-BAG PLUS CONTAINER NDC 00338-0553-18 FROM BAXTER HEALTHCARE CORP. NURSES HAVE REPORTED REPEATED EVENTS OF PRODUCT FAILURE. THE NURSES REPORT THAT WHEN REMOVING THE FOIL COVER, THE FOIL TEARS AWAY FROM THE BLUE CAP LEAVING THE BLUE CAP INSIDE THE DRUG VIAL ADAPTOR. THIS PREVENTS CONNECTION OF THE DRUG VIAL TO THE DRUG VIAL ADAPTOR. LOTS IDENTIFIED INCLUDE P195925 EXP. 10/07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-BAG PLUS 0.9% SODIUM CHLORIDE 100 ML KPE BAXTER HEALTHCARE CORP * P195925

    Patients

    Seq Age Sex Outcome Treatment
    1 *