BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET WITH CONV PINK, SEC CAP PORT, 1 CL

    MDR report key: 1181086 · Received September 29, 2008

    Report

    Report Number
    9615050-2008-00283
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K912103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. PRIOR TO PT USE, AFTER PRIMING THE TUBING SET WITH AN UNSPECIFIED SOLUTION, THE CUSTOMER CONTACT NOTED THE TUBING SEPARATED FROM 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 PRIMARY PLUM SET WITH CONV PINK, SEC CAP PORT, 1 CL 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA 640745H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA