BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 1064439 · Received June 23, 2008

    Report

    Report Number
    2027791-2008-00009
    Event Type
    Other
    Date Received
    June 23, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 23, 2008
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. PLEASE NOTE THAT THIS EVENT OCCURRED IN 2008, BUT WAS INITIALLY REPORTED TO BAXTER AND NOT EXCELSIOR. OUR FACILITY WAS NOT MADE AWARE OF THIS INCIDENT UNTIL BAXTER FORWARDED THE RELEVANT INFO TO US ON 06/17/2008. AN INITIAL REVIEW OF THE PRODUCTION RECORDS FOR LOT 62-048-9D SHOWS THAT THE HEPARIN API USED IN THE MANUFACTURE OF THESE SYRINGE (LOT 1035-0783) PASSED BOTH NUCLEAR MAGNETIC RESONANCE AND CAPILLARY ELECTROPHORESIS TESTING, SHOWING THAT THIS PARTICULAR BATCH OF HEPARIN API IS FREE OF OVER-SULFATED CHONDROITIN SULFATE. ALL ASSOCIATED BATCH RECORDS INDICATE THAT THE LOT SUCCESSFULLY PASSED STERILITY TESTING BEFORE ITS ULTIMATE RELEASE IN 2008. A COPY OF THE FDA HEPARIN QUESTIONNAIRE HAS BEEN MAILED TO THE CUSTOMER AND WE HOPE TO HAVE HIS RESPONSES SOMETIME WITHIN THE NEXT FEW DAYS. WE HAVE LIMITED INFO CONCERNING THIS INCIDENT AT THIS TIME, AS THE CUSTOMER HAS BEEN RELUCTANT TO DISCUSS DETAILS WITH US OVER THE PHONE AND HAS REPEATEDLY SAID THAT HE NEEDS TO CONSULT WITH HIS LAWYER BEFORE HE DIVULGES ANY FURTHER INFO. PER THE FDA'S REQUIREMENTS ON MDR REPORTING FOR HEPARIN ADVERSE EVENTS, WE ARE SUBMITTING THIS 5-DAY MDR WITH ALL THE DATA THAT IS CURRENTLY AVAILABLE. FOLLOW-UP REPORTS WILL BE MADE AS SOON AS WE ARE AWARE OF ADD'L INFO.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS INITIALLY FILED WITH BAXTER IN 2008. THE REPORT WAS FORWARDED TO EXCELSIOR THE FOLLOWING MONTH. IN THE BAXTER REPORT, THE CUSTOMER STATED THAT THEY HAD USED HEPARIN FROM AN UNK LOT NUMBER AND HAD EXPERIENCED STOMACH PAINS AND NAUSEA. THE CUSTOMER REPORTED THAT HE HAD JUST BEEN RELEASED FROM THE HOSPITAL. ONE DAY PRIOR, A REPRESENTATIVE FROM EXCELSIOR CONTACTED THE COMPLAINANT TO GATHER MORE INFO. THE COMPLAINANT NOTED THAT HE WAS STILL VERY SICK AND, WHEN ASKED FOR THE LOT NUMBER OF THE SYRINGE(S) HE HAD USED, HE REPORTED THAT THEY WERE CURRENTLY NOT IN HIS POSSESSION. OUR REPRESENTATIVE ASKED IF ANY SAMPLES COULD BE RETURNED FOR INSPECTION AND THE CUSTOMER SAID HE WOULD HAVE TO CONSULT HIS LAWYER. THE CUSTOMER WAS ALSO ASKED TO PROVIDE INFO REGARDING THE FDA'S STANDARDIZED QUESTIONNAIRE CONCERNING HEPARIN RELATED INCIDENTS. AGAIN, THE CUSTOMER RESPONDED THAT HE WOULD NEED TO DISCUSS THE ISSUE WITH HIS LAWYER FIRST. IT WAS THEN AGREED THAT THE QUESTIONNAIRE WOULD BE MAILED TO THE CUSTOMER, AT WHICH POINT HE STATED THAT "IT WAS OUR LUCKY DAY" AND THAT HE HAD A FEW SAMPLES AVAILABLE. HE THEN PROVIDED US WITH THE LOT NUMBER OF THOSE SAMPLES. THE FDA HEPARIN QUESTIONNAIRE HAS SINCE BEEN MAILED TO THE CUSTOMER AND WE AWAIT BOTH HIS RESPONSE AND THE RETURN OF THE SAMPLES IN HIS POSSESSION.

    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 62-048-9D

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O