BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN LOCK FLUSH, USP 100 UNITS/ML 5ML SYRINGE

    MDR report key: 1040352 · Received May 9, 2008

    Report

    Report Number
    MW5006794
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 23, 2008
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED NAUSEA, BAD TASTE, AND INCREASE IN MOUTH WATERING FOLLOWING HEPARIN FLUSHES. PATIENT HAD BEEN FLUSHING PICC LINE WITH HEPARIN ONCE A DAY WITH 500 UNITS/ 5 ML PREFILL FLUSH SYRINGE FROM EXCELSIOR MEDICAL. PATIENT WAS ON VANCOMYCIN USING SALINE - ANTIBIOTIC - SALINE - HEPARIN FLUSHING PROTOCOL. DUE TO THE NAUSEA, PATIENT WAS INSTRUCTED TO FLUSH WITH 250 UNITS/2.5 ML INSTEAD. SYMPTOMS DID NOT RECUR WITH THE LOWERED FLUSH. PACKAGE INSERT FOR THIS PRODUCT ALSO CONTAINS RECOMMENDATION TO LOWER RATE OF INFUSION TO MINIMIZE UNPLEASANT TASTE PATIENT MAY EXPERIENCE. DOSE OR AMOUNT: 500 UNITS/5 ML; FREQUENCY: QD; ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: OSTEOMYELITIS. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH, USP 100 UNITS/ML 5ML SYRINGE NONE NZW 61-052-9D

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR