BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHILED EXTENSION W/T PP

    MDR report key: 1062261 · Received June 17, 2008

    Report

    Report Number
    9613251-2008-00184
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 23, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 A DISCONNECTION. THE TUBING SET WAS CONNECTED TO A 24 GAUGE IV CATHETER AND WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THE SOLUTION HAD LEAKED AND THAT THE TUBING SET HAD DISCONNECTED FROM THE PATIENT'S IV CATHETER. THE TUBING SET WAS RECONNECTED TO THE CATHETER AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHILED EXTENSION W/T PP 80-FPA FPA HOSPIRA LTD. NA 56065NS

    Patients

    Seq Age Sex Outcome Treatment
    1 BABY UNSPECIFIED 24 GAUGE IV CATHETER| MANUFACTURED BY BECTON DICKINSON AND COMPANY