BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN LCK FLSH FT

    MDR report key: 1586208 · Received January 22, 2010

    Report

    Report Number
    1021343-2010-00012
    Event Type
    Injury
    Date Received
    January 22, 2010
    Date of Event
    November 13, 2007
    Report Date
    February 14, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    NZW
    PMA / PMN Number
    K005264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    REPORT 2 OF 2. THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THIS IS A COMBINATION PRODUCT THAT IS BEING REPORTED FOR THE DRUG PORTION OF THE PRODUCT. THE CONTACT REPORTED THAT THE HOMECARE PATIENT RECEIVED AN UNSPECIFIED VOLUME OF HEPARIN LOCK FLUSH SOLUTION, USP 100UNITS/ML (EXPIRATION DATE: 03/01/2009) TO A FLUSH A BROVIAC CATHETER. IT WAS REPORTED, THE PATIENT DEVELOPED A SEVERE HEADACHE. AT AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH INTRACRANIAL HYPERTENSION AND LASTING VISUAL PROBLEMS. THE PATIENT HAS BEEN HOSPITALIZED SIX TIMES. THE USE OF HEPARIN WAS DISCONTINUED AND THE BROVIAC CATHETER WAS REMOVED. NO FURTHER MEDICAL INTERVENTIONS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT IS STILL RECOVERING AND IMPROVING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LCK FLSH FT 80NGT NZW HOSPIRA, INC. NA 51283DK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| S