BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN LCK FLSH FT

    MDR report key: 1583457 · Received January 19, 2010

    Report

    Report Number
    1021343-2010-00004
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    NZW
    PMA / PMN Number
    K005264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. FOLLOWING INSERTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), THE PT WAS ADMINISTERED AN UNSPECIFIED VOLUME OF HEPARIN LOCK FLUSH SOLUTIONS, USP 10 UNITS/ML (EXPIRATION DATE; 12/1/2008). AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE "PT EXPERIENCED RASH/HIVES AND THEN THROAT SWELLED UP AND COULD NOT BREATH." THE PT WAS TREATED WITH UNSPECIFIED CONCENTRATIONS OF BENADRYL AND EPINEPHRINE. IT WAS REPORTED A "CODE CALLED" BUT THE PT WAS NOT "INTUBATED." THE "PT THEN BECAME HYPOTENSIVE AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU)." THE CUSTOMER CONTACT INDICATED THAT THE PT WAS REPORTED TO BE "RECOVERING." MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LCK FLSH FT 80NGT NZW HOSPIRA, INC. NA 54279DK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R