BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE

    MDR report key: 1231134 · Received October 30, 2008

    Report

    Report Number
    9615050-2008-00305
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 3, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED FLUSH SOLUTION FOLLOWING THE COMPLETION OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. IT WAS REPORTED THAT WHILE THE FLUSH SOLUTION WAS BEING DELIVERED, THE TUBING SEPARATED FORM THE LOWER CLAVE Y-SITE. THE THERAPY WAS COMPLETED; THEREFORE, THE TUBING SET WAS REMOVED AND WAS NOT REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA 661365H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK