BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2142672 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09134
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED LEAK CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THE LEAK CONDITION WAS DUE TO A ROUGH SURFACE ON THE INTERNAL DIAMETER OF THE WINGED LUER CAP. ADDITIONAL: A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT AN INTERMATE IN WHICH THERE WAS A LEAK. THE LEAK WAS NOTED DURING THE FINAL RELEASE INSPECTION AND NOT IMMEDIATELY AFTER FILL; THE BLUE WINGED LUER CAP WAS SECURE. THE UNIT WAS FILLED WITH 90 MILLIGRAMS PAMIDRONATE IN 250 MILLIGRAMS 0.9% SODIUM CHLORIDE. THERE WAS NO PATIENT INVOLVEMENT. 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 INTERMATE PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11B028

    Patients

    Seq Age Sex Outcome Treatment
    1 PAMIDRONATE, NACL