BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA

    MDR report key: 2503203 · Received March 15, 2012

    Report

    Report Number
    2503203
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    March 10, 2012
    Report Date
    March 15, 2012
    Manufacturer
    HOSPIRA
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE NOTED LIPIDS LEAKING FROM APPARENT CRACK IN CONNECTION. SHE ALSO STATED THAT IT APPEARS THAT THE MICROBORE TUBING IS NOT SCREWING IN SECURELY TO THE INTRALIPID SYRINGES. TWO SEPARATE INCIDENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA INTRAVASCULAR TUBING FPK HOSPIRA * 07220NS

    Patients

    Seq Age Sex Outcome Treatment
    1 * OTHER