BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SPIKE

    MDR report key: 1564938 · Received December 21, 2009

    Report

    Report Number
    MW5014105
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    December 4, 2009
    Report Date
    December 21, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE APPARATUS WE SET UP FOR OUR CHEMOTHERAPY INFUSIONS INVOLVE THE FOLLOWING 3 ITEMS: APPX 0.06ML BAG SPIKE, VENTED, CLAVE -LIST #20116-01, ICU MEDICAL, INC-, 5 IN -13CM- APPX 1.3ML, NON-DEHP BAG SPIKE ADPT SPIROS - LIST #Z7014, ICU MEDICAL, INC-, 150ML BURETTE PLUMSET, CONVERTIBLE PIN, 124 INCH - LIST #11948-02,ANOTHER COMPANY -. THE SPIKE END OF ITEM #1 ABOVE IS INSERTED INTO THE BOTTLE. THE SPIROS END OF ITEM #2 ATTACHES TO THE LUER-LOCK END OF ITEM #1. THE SPIKE END OF THE BURETTE -ITEM #3- IS INSERTED INTO THE OPPOSITE END OF ITEM #2 - THE OPPOSITE END OF THE LUER-LOCK-. DESCRIPTION OF THE PROBLEM: A LEAK WAS IDENTIFIED AT THE JUNCTION BETWEEN ITEM #2 AND ITEM #3 ABOVE. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CHEMOTHERAPY INFUSION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG SPIKE BAG SPIKE FPA ICU MEDICAL, INC. 20116-01 UNK
    2 ADPT SPIROS ADPT SPIROS FPA ICU MEDICAL, INC. Z7014
    3 BURETTE PLEMSET CONVERTIBLE PIN, 124 INCH FPA HOSPIRA, INC. 11948-02

    Patients

    Seq Age Sex Outcome Treatment
    1