BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1011646 · Received March 10, 2008

    Report

    Report Number
    9615050-2008-00061
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 NORMAL SALINE. THE CUSTOMER CONTACT REPORTED THAT AFTER ONE HOUR IN USE, THE NURSE ACCESSED THE DISTAL CLAVE Y-SITE OF THE TUBING SET AND ADMINISTERED 22ML OF AN UNSPECIFIED CONCENTRATION OF BLEOMYCIN IV PUSH FOR A DURATION OF 12 MINUTES. IT WAS REPORTED THAT FOLLOWING THE IV PUSH DELIVERY WHILE THE NURSE WAS IRRIGATED THE TUBING SET USING THE SAME DISTAL C/LAVE Y-SITE, THE TUBING SEPARATED FROM THE CLAVE Y-SITE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THROUGH 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 590305H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK