BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 2051008 · Received April 4, 2011

    Report

    Report Number
    9613251-2011-00050
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE OPENED POSITION; SUBSEQUENTLY, A LEAK OF A RADIOACTIVE ISOTOPE AND BLOOD LOSS WERE NOTED. THE MALE ADAPTER OF A 3-WAY STOPCOCK, WITH TWO FEMALE ADAPTERS, WAS CONNECTED TO THE REMOVABLE CLAVE PORT ON THE TUBING SET. THE SECURE LOCK OF THE TUBING SET WAS CONNECTED TO THE PT'S CATHETER. A SYRINGE CONTAINING 20-25 MILLICURIES/3ML OF TECHNETIUM WAS CONNECTED TO ONE OF THE TWO FEMALE ADAPTERS ON THE STOPCOCK. A SECOND SYRINGE CONTAINING 10ML OF NORMAL SALINE WAS CONNECTED TO THE OTHER FEMALE ADAPTER ON THE STOPCOCK. THE CUSTOMER CONTACT REPORTED THAT THE TECHNETIUM WAS DELIVERED IV PUSH FOLLOWED BY THE DELIVERY OF THE NORMAL SALINE FLUSH. IT WAS REPORTED THAT THE STOPCOCK WAS THEN DISCONNECTED FROM THE CLAVE PORT OF THE TUBING SET. AFTER THE STOPCOCK WAS DISCONNECTED, IT WAS NOTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE OPENED POSITION. AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE TUBING WAS "CLAMPED OFF" USING THE SLIDE CLAMP. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE REMOVABLE CLAVE PORT WAS REPLACED WITH A NEEDLELESS VALVE PORT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THIS 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 EXT SET 7IN REM CLAVE SITE NDEHP 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 3-WAY STOPCOCK, LIST # 42384, LOT# UNK,| MANUFACTURED BY ICU MEDICAL, INC.