BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PLM CONV PN CLAVE

    MDR report key: 1881435 · Received October 7, 2010

    Report

    Report Number
    9615050-2010-00187
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED NEEDLELESS T-CONNECTOR AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TAXOL. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED THE OPTION-LOK MALE ADAPTER DISCONNECTED FROM THE NEEDLELESS T-CONNECTOR. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF TAXOL LEAKED. THE TAXOL THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE PRIMARY TUBING SET WAS REPLACED AND THE DELIVERY WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS PLM CONV PN CLAVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1