BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60" HIGH FLOW RATE EXTENSION SET

    MDR report key: 2040415 · Received April 5, 2011

    Report

    Report Number
    6000001-2011-02585
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. THE MALE LUER WAS OBSERVED TO BE BROKEN. THIS COMPONENT IS PURCHASED FROM A SUPPLIER AND A SUPPLIER CORRECTIVE ACTION REPORT WAS SUBMITTED TO THEM. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED AN ADDITIONAL SAMPLE OF THE 60" HIGH FLOW RATE EXTENSION SET, PRODUCT CODE 2N3349, LOT NUMBER UNKNOWN, FOR EVALUATION. THROUGH EVALUATION, THE RETURNED SAMPLE WAS DETERMINED TO BE BROKEN. THE MALE LUER TIP WAS RECEIVED BROKEN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITION INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60" HIGH FLOW RATE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1