BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENDALL/TYCO/COVIDIEN PREFILLED HEPARIN 100 UNITS/ML

    MDR report key: 1071549 · Received July 9, 2008

    Report

    Report Number
    MW5007551
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    February 19, 2008
    Report Date
    July 7, 2008
    Manufacturer
    KENDALL/TYCO/COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD BEEN FLUSHING HER PICC LINE WITH HYPERSULFATED HEPARIN. SHE DEVELOPED AN INFLAMMATORY RESPONSE LOCALIZED TO CHEST, NECK AND ARMS. SHE DEVELOPED CHEST PAIN SIMILAR TO AMI WITH ASSOCIATED STRANDING IN THE PERICARDIAL FAT PAD. SHE DEVELOPED SWELLING OF THE LEFT NECK, AND ARM AND SUPRACLAVICULAR NECK AREA. LAB WORK REVEALED ELEVATED ESR AT 63. PT DEVELOPED EXTENSIVE DVT OF BRACHIOCEPHALIC LEFT IJ AND LEFT SUBCLAVIAN -BEYOND THAT WOULD BE EXPECTED IN A PT WITH NO SIGNIFICANT TUMOR BURDENS AND AN IV HEPARIN FLUSHES. PT HAS NEW DIAGNOSIS OF HYPOTHYROIDISM NOW. SHE ALSO EXPERIENCED INTOLERABLE PAIN WITH PLEURITIC AND ANGINAL CHARACTERISTICS. THIS WOULD NOT HAVE BEEN ANTICIPATED FROM HER CHEMOTHERAPY PORTACATH COMPLICATIONS OR DISEASE. DOSE OR AMOUNT: 2.5 - 5ML DAILY, FREQUENCY: 1-2Y DAILY, ROUTE: PICC LINE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: FLUSH PICC LINE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL/TYCO/COVIDIEN PREFILLED HEPARIN 100 UNITS/ML PREFILLED HEPARIN 100 UNITS/ML NZW KENDALL/TYCO/COVIDIEN 7113114
    2 KENDALL/TYCO/COVIDIEN PREFILLED HEPARIN 100 UNITS/ML PREFILLED HEPARIN 100 UNITS/ML NZW KENDALL/TYCO/COVIDIEN 8010114
    3 KENDALL/TYCO/COVIDIEN PREFILLED HEPARIN 100 UNITS/ML PREFILLED HEPARIN 100 UNITS/ML NZW KENDALL/TYCO/COVIDIEN 8010174

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L CHEMO TREATMENT| PICC LINE PLACEMENT