BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR SV2.5 ML/H

    MDR report key: 1781624 · Received August 3, 2010

    Report

    Report Number
    6000001-2010-02328
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE TO BAXTER FOR EVALUATION. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT MENTIONED IN THIS REPORT, FOLFUSOR, WAS REPORTED ERRONEOUSLY. THERE WAS NOT A PRODUCT COMPLAINT. THIS REPORT WILL BE RETRACTED.

    Description of Event or Problem · 1

    (COMPLAINT 16 OF 20). THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A FOLFUSOR THAT HAD LEAKAGE THROUGH THE WINGED LUER CAP. THE EVENT OCCURRED DURING USE. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR SV2.5 ML/H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09E069

    Patients

    Seq Age Sex Outcome Treatment
    1