BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF REG EXT SET NON-DEHP

    MDR report key: 3093471 · Received April 26, 2013

    Report

    Report Number
    9613251-2013-00113
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 LEAK. ON AN UNSPECIFIED DATE, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE TUBING SET WAS RETURNED TO THE PURCHASING MANAGER WITH A NOTE THAT STATED, ¿COMING OUT THROUGH THE BLUE DIAL.¿ NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADD¿L INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182189 LS LF REG EXT SET NON-DEHP 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA