BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3802754 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01417
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 24, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE DEPRESSED POSITION. THE TUBING SET WAS BEING USED TO DELIVER 50 ML OF AN UNSPECIFIED CONCENTRATION OF VINCRISTINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A UNSPECIFIED 60 ML SYRINGE WAS CONNECTED TO THE CLAVE Y-SITE OF THE TUBING SET FOR AN IV PUSH DELIVERY OF DOXORUBICIN. IT WAS REPORTED THAT AFTER 5-10 MINS, APPROXIMATELY 25 ML OF SOLUTION HAD LEAKED FROM THE CLAVE Y-SITE. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. IT WAS REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT AT THE Y-SITE OF THE TUBING SET REMAINED IN THE DEPRESSED POSITION. THE TUBING SET AND MEDICATION WERE REPLACED AND THE THERAPY WAS RESUMED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED A DELAY OF THERAPY OF APPROXIMATELY 45 MINS. HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MED INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108938 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 261115H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED 60ML SYRINGE, MFR UNK