BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFURCATED POSIFLOW EXTENSION SET

    MDR report key: 1100403 · Received July 25, 2008

    Report

    Report Number
    1100403
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MPS ACACIA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TUBING BROKE WHEN THE NURSE WAS CHANGING THE TUBING, LEAVING THE END IN THE BROVIAC. THERE WERE UNSUCCESSFUL ATTEMPTS TO REMOVE THE TUBING. A DECISION WAS MADE TO DISCONTINUE THE BROVIAC. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFURCATED POSIFLOW EXTENSION SET IV, EXTENSION FPA MPS ACACIA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA