BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 2941291 · Received January 25, 2013

    Report

    Report Number
    MW5028790
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 25, 2013
    Manufacturer
    CARE FUSION CORP
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAS A PICC LINE INSERTED TO LEFT CHEST AREA. SHE COMES TO (B)(6) FOR CUBICIN IV. CUBICIN WAS HUNG AND HAD INFUSED ABOUT 6 MINUTES AND (B)(6) SAW THE PT'S SHIRT WAS WET. THE TUBING HAD BROKEN FROM END, LEAVING THE PT'S LINE OPEN AND BLEEDING. THE PORT WAS CLAMPED AND CUBICIN STOPPED. PHARMACY WAS NOTIFIED FOR NEW BAG OF CUBICIN. MATERIALS MANAGEMENT WAS NOTIFIED ABOUT THE PRIMARY TUBE BREAKING. PT WAS NOT HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36130 SMARTSITE INFUSION SET INFUSION SET FPA CARE FUSION CORP 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR