BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 1039607 · Received May 9, 2008

    Report

    Report Number
    2027791-2008-00004
    Event Type
    Other
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 7, 2008
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXCELSIOR MEDICAL IS WORKING TO GATHER FURTHER DETAILS FROM THE COMPLAINANT AND IS ATTEMPTING TO SECURE THE SUSPECT DEVICE(S) FOR INSPECTION. WE HAVE OPENED AN OFFICIAL COMPLAINT THAT COMBINES BOTH ADVERSE EVENTS FROM REPORTS 2027791-2008-00004 AND 00005 PRIOR TO THESE TWO INCIDENTS, EXCELSIOR FILED TWO SEPARATE MDRS CONCERNING HEPARIN ADVERSE EVENTS (#'S 2027791-2008-00001 AND 00003). ASIDE FROM THE EVENTS NOTED IN THE AFOREMENTIONED MDRS, A REVIEW OF COMPLAINTS REC'D OVER THE PAST TWO YEARS HAS NOT REVEALED ANY OTHER HEPARIN RELATED INCIDENTS. TO DATE, EXCELSIOR HAS ATTEMPTED TO CONTACT THE COMPLAINANT AND THE PHYSICIAN REFERENCED BY HER. DESPITE REPEATED ATTEMPTS, NEITHER OF THEM COULD BE REACHED AT THE TIME THIS MDR WAS FILED. NEVERTHELESS, WE ARE FILING THIS MDR WITH THE CURRENTLY AVAILABLE INFO IN ACCORDANCE WITH THE FDA'S 5 DAY REPORTING REQUIREMENT FOR ADVERSE EVENTS ASSOCIATED WITH HEPARIN-CONTAINING PRODUCTS. WE ARE CURRENTLY IN THE PROCESS OF GATHERING MORE INFO AND ADD'L DETAILS WILL BE GIVEN AS SOON AS RELEVANT DATA IS AVAILABLE.

    Description of Event or Problem · 1

    TWO SEPARATE ADVERSE EVENTS WERE REPORTED TO EXCELSIOR MEDICAL IN A SINGLE EMAIL ON 05/04/2008 BY AN RN WHO WAS ADMINISTERING OUR PRODUCT IN A HOME SETTING. BOTH EVENTS AFFECTED THE SAME PT. THE FIRST EVENT WILL BE DETAILED IN THIS REPORT (2027791-2008-00004) AND THE SECOND EVENT WILL BE DOCUMENTED IN 2027791-2008-00005. THE FIRST EVENT OCCURRED IN 2008. THE NURSE REPORTED THAT 1 HR AFTER FLUSHING THE PT'S CENTRAL LINE, THE PT EXPERIENCED WHAT WAS DESCRIBED AS "SEIZURE LIKE" SYMPTOMS. THESE INCLUDED HIS JAW CLENCHING DOWN, HEAD PULLING TO THE LEFT AND UNCONTROLLED CHATTERING OF HIS CHIN. THE SYMPTOMS PASSED WITHIN 30 MINUTES BUT THE PT CLAIMED TO BE FEELING UNWELL FOR THE REST OF THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE 100 U/ML HEPARIN LOCK FLUSH SYRINGE NZW EXCELSIOR MEDICAL CORP. NA 12-015-DS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other SALINE".| INSTILLED 100 BNS BEFORE LOCKING WITH HEPARIN| FLUSH. ALTHOUGH RN DID NOT SPECIFY WHAT| BNS WAS