BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD EXT SET WITH LOCKING LUER 'T'

    MDR report key: 1052471 · Received May 22, 2008

    Report

    Report Number
    9613251-2008-00161
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 30, 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

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SEPARATED FROM THE FEMALE ADAPTER. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. 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 WITH LOCKING LUER 'T' 80-FPA FPA HOSPIRA, LTD NA 59030NS

    Patients

    Seq Age Sex Outcome Treatment
    1