BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 1288492 · Received January 14, 2009

    Report

    Report Number
    2027791-2009-00001
    Event Type
    Other
    Date Received
    January 14, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 14, 2009
    Manufacturer
    EXCELSIOR MEDICAL CORPORATION
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF EXCELSIOR MEDICAL'S STANDARD OPERATING PROCEDURES, WE HAVE OPENED A COMPLAINT FILE ON THIS INCIDENT. EXCELSIOR IS FILING THIS REPORT TO COMPLY WITH THE FDA'S 5-DAY MDR REPORTING MANDATE CONCERNING POTENTIAL HEPARIN ADVERSE EVENTS. INITIAL INFORMATION ABOUT THE EVENT SEEMS TO INDICATE THAT THE ADVERSE EVENT WAS DUE TO AN INFECTION FROM AN UNKNOWN SOURCE. THE SYMPTOMS REPORTED BY THE PATIENT (REDNESS AND SWELLING AT SITE OF ADMINISTRATION) AND THE DELAYED ONSET OF THESE PROBLEMS SUGGEST THAT THE REPORTED ADVERSE REACTION IS NOT RELATED TO EXCELSIOR'S HEPARIN API. WE WILL CONTINUE TO SEEK MORE INFORMATION FROM THE COMPLAINANT AND PATIENT INVOLVED AND WILL ATTEMPT TO SECURE THE SUSPECT DEVICE FOR EVALUATION. FURTHER INFORMATION WILL BE PROVIDED AS IT BECOMES AVAILABLE TO US.

    Description of Event or Problem · 1

    IN 2009, EXCELSIOR WAS CONTACTED BY REP, A PHARMACIST FROM PHARMACY. REP TOLD EXCELSIOR THAT A POTENTIAL ADVERSE EVENT INVOLVING HEPARIN HAD BEEN REPORTED TO HIM BY HOSPICE. HE NOTED THE LOT NUMBER AND PRODUCT CODE INVOLVED IN THE REPORT AND PROVIDED CONTACT INFORMATION FOR THE HOSPICE SERVICE. EXCELSIOR MADE CONTACT WITH DIRECTOR OF CLINICIANS FOR HOSPICE. THE REPORTER, NOTED THAT THE SUBJECT HEPARIN WAS ADMINISTERED IN 2008, AND THAT A REACTION WAS SEEN FOUR DAYS LATER. THIS INCLUDED CLASSIC SIGNS OF INFECTION, SUCH AS SWELLING AND REDNESS AT THE SITE OF ADMINISTRATION. THE HEPARIN WAS ADMINISTERED THROUGH A MEDIPORT SITE IN ORDER TO KEEP THE LINE PATENT. PATIENT IS CURRENTLY BEING TREATED FOR NON-HODGKIN'S LYMPHOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE 5ML, 100 U/ML HEPARIN LOCK FLUSH SYRINGE NZW EXCELSIOR MEDICAL CORPORATION NA 67-011-9D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CODIENE| WARFARIN| HUMULIN R| CLONIDINE| LISINOPRIL| ACIPHEX| PATIENT IS ON THE FOLLOWING MEDICATION REGIMEN:| BLIPIZIDE| METFORMIN| REMERON| LOMOTIL| LEXAPRO