BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 1239843 · Received November 20, 2008

    Report

    Report Number
    2027791-2008-00010
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 18, 2008
    Manufacturer
    EXCELSIOR MEDICAL
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE EXCELSIOR'S 9TH MDR WE HAVE FILED REGARDING POSSIBLE HEPARIN ADVERSE EVENTS. ALL OF THESE MDRS HAVE BEEN FILED IN ACCORDANCE WITH THE FDA'S MANDATED "5-DAY" POLICY REGARDING HEPARIN ADVERSE EVENTS. OF THE PREVIOUS 8 INCIDENTS, INVESTIGATIONS HAVE SHOWN THAT 6 WERE NOT THE RESULT OF EXCELSIOR'S HEPARIN PRODUCTS AND 2 ARE STILL CURRENTLY UNDER INVESTIGATION. A REVIEW OF PRODUCTION RECORDS WAS CONDUCTED FOR LOT 21-003-DS. NO DEVIATIONS OR MANUFACTURING ABNORMALITIES WERE FOUND TO BE PRESENT. ADDITIONALLY, THE HEPARIN API LOT (1035-0813) USED IN THE PRODUCTION OF THIS SYRINGE BATCH, HAS BEEN TESTED UTILIZING NUCLEAR MAGNETIC RESONANCE (NMR) AND CAPILLARY ELECTROPHORESIS (CE). THE SUBJECT HEPARIN API WAS FOUND TO BE CLEAR OF OVER-SULFATED CHONDROITIN SULFATE. THE PHARMACY THAT SUPPLIED THE HEPARIN SYRINGES, INFUSION SPECIALTIES, WAS CONTACTED AND THEY DO NOT BELIEVE THE PATIENT'S SYMPTOMS WERE CAUSED BY THE HEPARIN. THE PROPOSED THAT IT MAY HAVE BEEN AN ALLERGIC REACTION TO THE ROCEPHRINE AND INSTRUCTED HER TO DISCONTINUE ITS USE FOR A 5 DAY PERIOD. EXCELSIOR IS STILL CONDUCTING ITS INVESTIGATION AND IS WORKING TO GATHER ADDITIONAL INFORMATION REGARDING THIS INCIDENT. WE ARE CURRENTLY ATTEMPTING TO CONTACT THE PATIENT'S PRIMARY CARE PHYSICIAN FOR AN INTERVIEW AND WE ARE WORKING WITH THE COMPLAINANT TO RETRIEVE THE SUBJECT SYRINGE(S) FOR INSPECTION.

    Description of Event or Problem · 1

    ON THE EVENT DATE, MINUTES AFTER FLUSHING WITH HEPARIN, PATIENT EXPERIENCED INTERMITTENT SHORTNESS OF BREATH, TINGLING IN HER LIPS, HANDS, AND FEET AND LIGHTHEADEDNESS. THIS CONTINUED INTO THE NIGHT. ABOUT 1 HOUR AFTER THE START OF THE SYMPTOMS, PATIENT LOST COORDINATION AND FELL TO THE FLOOR, HOWEVER, SHE DID NOT LOSE CONSCIOUSNESS. THE NEXT DAY SHE FELT WEAK AND LETHARGIC. THESE SYMPTOMS, WITH THE EXCEPTION OF THE LOSS OF COORDINATION, HAD BEEN OCCURRING INTERMITTENTLY AND IN VARYING STAGES SINCE 2008, HOWEVER, THEY WERE THE MOST SIGNIFICANT ON THE EVENT DATE. THE PATIENT CONTACTED HER DOCTORS THE NEXT DAY AND THEY FELT IT COULD BE AN ALLERGIC REACTION TO THE ANTIBIOTIC SHE IS RECEIVING OR THE HEPARIN. SHE WAS INSTRUCTED TO DISCONTINUE THE ANTIBIOTIC FOR FIVE DAYS (2008), BUT THE SYMPTOMS CONTINUED. SHE WAS THEN INSTRUCTED TO DISCONTINUE THE HEPARIN UNTIL FURTHER NOTICE. SINCE THE PATIENT DISCONTINUED THE USE OF THE HEPARIN, SHE HAS ONLY EXPERIENCED MODERATE CHEST PAIN. THE PATIENT IS CURRENTLY FLUSHING WITH SALINE AT THIS TIME. AT THE TIME THIS REPORT WAS WRITTEN, THE PATIENT IS NO LONGER TAKING ANTIBIOTICS OR HEPARIN.

    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 NA 21-003-DS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other