BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN LOCK FLUSH

    MDR report key: 1001438 · Received February 19, 2008

    Report

    Report Number
    MW5005608
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 19, 2008
    Manufacturer
    SIERRA PRE-FILLED INC/AM2 PAT
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHARMACY-OPTION CARE INC FAILED TO NOTIFY US THAT WE WERE SHIPPED HEPARIN AND SALINE SYRINGES WHICH WERE LATER RECALLED. DOSE OR AMOUNT: 3ML, FREQUENCY:2/DAY, ROUTE: IV. DOSE OR AMOUNT: 10ML, FREQUENCY: AS NEEDED, ROUTE: IV. DATES OF USE 2008. DIAGNOSIS OR REASON FOR USE, NOT NEEDED, NEVER USED. (DAILY FLUSH OF BROVIAC, CENTRAL LINE PORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH 10 UNITS/ML NZW SIERRA PRE-FILLED INC/AM2 PAT
    2 SALINE FLUSH 10 ML NGT SIERRA PRE-FILLED INC/AM2 PAT

    Patients

    Seq Age Sex Outcome Treatment
    1 YR