BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD EXT SET W/LOCKING LUER 'T'

    MDR report key: 1052469 · Received May 22, 2008

    Report

    Report Number
    9613251-2008-00160
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K941214
    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 INDICATED THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONTRAST MEDIA AND WAS CONNECTED TO A POWER INJECTOR. THE CUSTOMER CONTACT REPORTED THAT AFTER SLIDING THE GREEN SLIDE CLAMP INTO THE CLOSED POSITION, THE CONTRAST CONTINUED TO "TRICKLE" PAST THE CLAMP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD EXT SET W/LOCKING LUER 'T' 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED CONTRAST MEDIA| UNSPECIFIED POWER INJECTOR