BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS CLAVE PORT EXT 7"

    MDR report key: 1203405 · Received October 15, 2008

    Report

    Report Number
    9613251-2008-00364
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 23, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K915571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 A TUBING SEPARATION; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PROPOFOL. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CLAVE SEPARATED FROM THE TUBING. THE CUSTOMER CONTACT REPORTED A "MINIMAL AMOUNT" OF BLOOD WAS LOST. REPORTEDLY, THE TUBING AND THE CLAVE WERE RECONNECTED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CLAVE PORT EXT 7" 80-FPA FPA HOSPIRA LTD. NA 56096NS

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT