BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD EXTENSION W/T PP

    MDR report key: 1062259 · Received June 17, 2008

    Report

    Report Number
    9613251-2008-00183
    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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 DISCONNECTION; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED 26 GAUGE IV CATHETER AND WAS BING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THE TUBING SET HAD DISCONNECTED FROM THE PATIENT'S IV CATHETER AND BLOOD LOSS WAS NOTED. THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 3ML. 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 LIFESHIELD EXTENSION W/T PP 80-FPA FPA HOSPIRA LTD. NA 56065NS

    Patients

    Seq Age Sex Outcome Treatment
    1 BABY MANUFACTURER UNK| UNSPECIFIED 26 GAUGE IV CATHETER