BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 1048462 · Received May 20, 2008

    Report

    Report Number
    2027791-2008-00006
    Event Type
    Other
    Date Received
    May 20, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 2008
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 AT OUR FACILITY FOR THIS ADVERSE EVENT. CURRENTLY, THERE IS INSUFFICIENT INFO TO FIRMLY IMPLICATE ONE OF EXCELSIOR'S HEPARIN PRODUCTS FROM LOT 16-004-DS IN THIS EVENT. ACCORDING TO DISCUSSIONS WITH THE COMPLAINANT, THEY HAVE BEEN RECEIVING FLUSH SYRINGES FROM BOTH EXCELSIOR AND MEDEFIL AND THEY ARE UNSURE AS TO WHICH SYRINGE BRAND WAS USED JUST PRIOR TO THE ADVERSE EVENTS. A REVIEW OF RECALLED PRODUCTS ON THE FDA'S WEBSITE HAS SHOWN THAT A RECALL OF MEDEFIL HEPARIN IV FLUSH SYRINGES (100 UNITS/ML) WAS POSTED IN 2008. IN LIGHT OF THIS FACT, IT IS POSSIBLE THAT ONE OF THE MEDEFIL SYRINGES USED BY THE COMPLAINANT WAS RESPONSIBLE FOR THE ADVERSE EVENT. THE PHARMACY THAT SUPPLIED THE COMPLAINANT WITH THE SUSPECT SYRINGES WAS CONTACTED AND THEY STATED THAT THEY HAVE 25-30 PATIENTS RECEIVING THIS PRODUCT AS WELL AND THEY HAVE HAD NO COMPLAINTS. THE PHARMACIST ALSO SAID THAT THE PT IS ON AN ANTIBIOTIC THAT IS KNOWN FOR SYMPTOMS SUCH AS THOSE REPORTED AND THAT COULD BE THE PROBLEM. PHARMACY CONTACT: ONE SOURCE. ADDITIONALLY, THE DOCTOR WHO TREATED THE PT AT THE ER SAID THAT HE FELT THE CAUSE OF THE PT'S SYMPTOMS WAS PROBABLY NOT RELATED TO THE HEPARIN AND THAT THE INITIAL FINDINGS FOR HER REACTION WERE, IN HIS WORDS, "INCONCLUSIVE". A HISTORICAL REVIEW OF COMPLAINTS REGARDING EXCELSIOR'S HEPARIN PRODUCTS WAS CONDUCTED. RECORDS SHOW THAT EXCELSIOR RECEIVED A TOTAL OF 7 MEDICAL DEVICE REPORTABLE EVENTS OVER THE PAST TWO YEARS (EXCLUDING THIS REPORT). OF THESE, 4 CONCERNED HEPARIN PRODUCTS. ALTHOUGH THESE ARE STILL UNDER INVESTIGATION, WE HAVE RECEIVED INFO INDICATING THAT NONE OF THE ASSOCIATED LOTS WERE CONTAMINATED BY OVER-SULFATED CHONDROITIN SULFATE. EXCELSIOR HAS TESTED ALL OF OUR AVAILABLE HEPARIN LOTS AND FOUND THAT THEY COMPLY WITH THE NUCLEAR MAGNETIC RESONANCE (NMR) AND CAPILLARY ELECTROPHORESIS (CE) TESTING REQUIREMENTS MANDATED BY THE FDA. ALTHOUGH EXCELSIOR MEDICAL DOES NOT BELIEVE OUR PRODUCT IS RESPONSIBLE FOR THE COMPLAINANT'S REPORTED SYMPTOMS, WE ARE FILING THIS MDR OUT OF AN EXCESS OF CAUTION AND TO COMPLY WITH THE FDA'S 5-DAY MANDATE ON REPORTING HEPARIN EVENTS.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT HIS WIFE EXPERIENCED TWO ADVERSE REACTIONS THAT THEY BELIEVED TO BE LINKED TO HEPARIN FLUSHES. THE PT HAD BEEN ON THE SAME MEDICATION REGIMEN FOR OVER A MONTH WITHOUT SIGNIFICANT CHANGES UNTIL SHE BEGAN USING A NEW BATCH OF HEPARIN PRE-FILLED SYRINGES. THE FIRST ADVERSE EVENT OCCURRED RIGHT AFTER ADMINISTRATION OF THE NEW HEPARIN BATCH. THE PT IGNORED THE SYMPTOMS AND ADMINISTERED THE FLUSH(S) THE NEXT DAY. THE SYMPTOMS DURING THE SECOND ADVERSE EVENT WERE BAD ENOUGH THAT THE PT HAD TO BE TAKEN TO THE ER IN 2008. THE PT'S SYMPTOMS INCLUDED STRONG NAUSEA, DIARRHEA, AND LOW BP. THE COMPLAINANT ALSO STATED THAT WHEN THEY WENT TO THE EMERGENCY ROOM AFTER THE SECOND REACTION, THE DOCTOR'S FINDINGS REGARDING HIS WIFE'S REACTION WERE "INCONCLUSIVE". THE DOCTOR DID NOT/WOULD NOT STATE THAT THE HEPARIN WAS THE CAUSE AND FELT THAT IT PROBABLY WASN'T. A STOOL SAMPLE WAS TAKEN, BUT THE RESULTS ARE NOT YET AVAILABLE. DURING THE CONVERSATION WITH THE COMPLAINANT, HE STATED THAT THEY HAD BEEN RECEIVING TWO DIFFERENT BRANDS OF HEPARIN PRE-FILLED FLUSHES AND WERE NOT SURE WHICH BRAND HAD BEEN USED PRIOR TO THE ADVERSE REACTION. THE OTHER BRAND IS MEDEFIL, LOT H108170, EXP 03/2010. BOTH EXCELSIOR AND MEDEFIL USED SYRINGES WERE IN THE TRASH WHEN THEY LOOKED.

    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 CORP. NA 16-004-DS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O MILOXICON 15MG 1X A DAY| ROSEPHRINE 2MG 2X A DAY| PLACKNIL 200MG 2X A DAY| SEPTRA 2X A DAY| BIAXIN 500ML 2X A DAY| METPRON 10ML 2X A DAY| TOPRALL 25MG 1X A DAY