BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN 10 UNITS / ML (5 ML)

    MDR report key: 1040351 · Received May 9, 2008

    Report

    Report Number
    MW5006793
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 17, 2008
    Report Date
    April 19, 2008
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT ON IV ANTIBIOTICS AFTER DISCHARGE FROM HOSPITAL FOR PNEUMONIA - PT TRACHED/VENTED MEDICALLY FRAGILE CHILD. ANTIBIOTICS TO BE GIVEN AT HOME IN IV CATH /IV PORT IN HIS CHEST BY CAREGIVER - TID - SALINE 10CC - ANTIBIOTICS - HEPARIN 5CC, SALINE 10CC (SASH), PT BEGAN VOMITING REPEATEDLY - LOOSE WATERY STOOLS - PROFUSE SWEATING - ABD PAIN - PT HAS HIGH B/P HIS B/P DURING THESE EPISODES WAS NORMAL/LOW. HE HAD RED PATCHES ABOUT HIS BODY & SWOLLEN EYELIDS - HE WAS VERY SICK FOR ABOUT 2 PLUS WEEKS. NO TESTED - PT WAS READMITTED TO HOSPITAL -DUE TO NOT KNOWING ABOUT THE HEPARIN RECALL, IT WAS ASSUMED HE HAD SEVERE CASE OF THE FLU. TUBE FED - NEW FOODS THAT WE LET HIM TASTE HE HAS ALLERGIES TO - CP SPASTIC QUAD - TRACH/VENTED SEVERE EVER MULTI IMPAIRED. DOSE OR AMOUNT: 5ML; FREQUENCY TID X 10 DAYS; ROUTE: IV CATH. DATES OF USE: 2008. DIAGNOSIS: ON IV ANTIBIOTICS TID VIA PORT FOR SEPTICEMIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN 10 UNITS / ML (5 ML) NONE NZW H07325
    2 HEPARIN 10 UNITS / ML (5ML) NONE NZW H08113

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| O HEPARIN 10 UNITS/ML| 5 ML TID X 10 DAYS| START