BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1170792 · Received September 15, 2008

    Report

    Report Number
    9615050-2008-00265
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. PRIOR TO PT USE WHILE PRIMING THE TUBING SET WITH A SALINE SOLUTION, THE CUSTOMER CONTACT NOTED THE TUBING SEPARATED FROM THE LEG OF THE CLAVE Y-SITE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFO 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 641105H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA