BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT RESISTANT

    MDR report key: 2854309 · Received October 23, 2012

    Report

    Report Number
    2854309
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SMITH MEDICAL NORTH AMERICA
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    AMBER COLORED TUBING INFUSING TACROLIMUS (MEDICATION) BROKE WHERE TUBING INSERTS INTO PLASTIC PIECE THAT CONNECTS TO THE MAIN IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT RESISTANT TUBING, FLUID DELIVERY FPK SMITH MEDICAL NORTH AMERICA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO