BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEP LOCK FLUSH FT 30

    MDR report key: 1583460 · Received January 19, 2010

    Report

    Report Number
    1021343-2010-00008
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    October 1, 2006
    Report Date
    October 9, 2006
    Manufacturer
    HOSPIRA, INC.
    Product Code
    NZW
    PMA / PMN Number
    K005264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 AN UNSPECIFIED VOLUME OF HEPARIN LOCK FLUSH SOLUTION USP 100UNITS/ML (EXPIRATION DATE: 10/01/2007), WAS USED TO FLUSH THE PT'S PORTACATH. IT WAS REPORTED THAT THE PT EXPERIENCED LACK OF EFFECT AND DEVELOPED THROMBOSIS IN THE PORTACATH. THE PORTACATH WAS DECLOTTED WITH AN UNSPECIFIED ANTI-THROMBOLYTIC MEDICATION. NO FURTHER MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEP LOCK FLUSH FT 30 80NGT NZW HOSPIRA, INC. NA 40164DK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R