BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2963715 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03926
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: ONE USED SAMPLE WAS RECEIVED, WHICH ARRIVED FULLY PRIMED WITH THE SPIKE IN THE CLOSED POSITION. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION COULD NOT BE CONFIRMED, AS NO MALFUNCTIONS WERE OBSERVED. THEREFORE NO CAUSE COULD BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE IS NOT AVAILABLE SO THE REPORTED CONDITION CANNOT BE CONFIRMED AND THE ROOT CAUSE CANNOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN FROM THE INVESTIGATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER HEALTHCARE ONE (1) INTERLINK SECONDARY MEDICATION SET WITH DUO-VENT SPIKE IN WHICH A NO FLOW WAS DETECTED WHEN SPIKING A 1000MG BOTTLE OF NON-BAXTER IV ACETAMINOPHEN DURING SETUP. THE CUSTOMER OBSERVED THAT THE VENTED PORTION OF THE SPIKE WOULD OPEN, BUT WOULD NOT ALLOW THE MEDICATION TO FLOW. THERE IS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67868 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1