BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 3111677 · Received May 7, 2013

    Report

    Report Number
    9613251-2013-00135
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE MALE ADAPTER OF AN UNSPECIFIED PRIMARY TUBING SET WAS CONNECTED TO THE CLAVE PORT OF THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. THE OPTION-LOK MALE ADAPTER OF THE EXTENSION TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE PATIENT¿S INTERNAL JUGULAR CATHETER. THE CUSTOMER CONTACT REPORTED THAT AFTER THE DELIVERY WAS COMPLETE, THE NURSE DISCONNECTED THE MALE ADAPTER OF THE PRIMARY TUBING SET FROM THE CLAVE PORT OF THE EXTENSION TUBING SET. AT THIS TIME, IT WAS REPORTED THAT THE CLAVE PORT SEPARATED FROM THE SEMI-RIGID FEMALE ADAPTER OF THE EXTENSION TUBING SET. THE EXTENSION TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197919 LSLF EXT SET W CLV 80FPA FPA HOSPIRA LTD. NA 20054NS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR