BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1862581 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03908
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE HAS BEEN DETERMINED TO BE A LOSE WINGED LUER CAP. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT MORE THAN TWENTY (SPECIFIC NUMBER OF UNITS IS UNKNOWN) INTERMATES IN WHICH THE LABELS WERE SOAKED AND THERE WAS LIQUID IN THE AMBER PACKAGING. THE CUSTOMER EXPLAINED THAT THE LEAK CAME FROM THE WING LUER CAP, WHICH POSSIBLY BECAME LOOSE DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE EVENT OCCURRED BEFORE PATIENT USE. IT WAS REPORTED TO BAXTER ON 16 SEPTEMBER 2010 THAT ONE UNIT WAS RECEIVED FROM THE CUSTOMER FOR THE LEAKING ISSUE. THE UNIT CONTAINED PAMIDRONATE 90 MILLIGRAMS IN 250 MILLILITERS NORMAL SALINE. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B050

    Patients

    Seq Age Sex Outcome Treatment
    1