BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLAVE BAG SPIKE & 5"SPIKE ADAPTOR W/SPIROS

    MDR report key: 1732091 · Received June 10, 2010

    Report

    Report Number
    2025816-2010-00029
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    December 4, 2009
    Report Date
    December 21, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL #: Z7014 AND CATALOG #: Z7014.

    Description of Event or Problem · 1

    COMPLAINT REC'D VIA FDA/MAUDE FOI REPORTING A CHEMO LEAKAGE INCIDENT INVOLVING ICU DEVICES, 20116-01 CLAVE VENTED BAG SPIKE AND A Z7014 5" VENTED BAG SPIKE W/SPIROS USED WITH THE HOSPIRA 11948-02 LIFESHIELD PLUM SET. THE REPORT DESCRIBES THE SET-UP AS FOLLOWS: THE 20116-01 "SPIKE END WAS INSERTED INTO THE BOTTLE" THE Z7014 "SPIROS END... ATTACHES TO THE LUER LOCK END OF THE 20116-01. THE "SPIKE END OF THE (HOSPIRA 11948-02 LF PLUM SET) IS INSERTED INTO THE OPPOSITE END OF THE Z7014. A LEAK WAS IDENTIFIED AT THE JUNCTION OF THE Z7014 AND THE HOSPIRA 11948-02 SET. THE MAUDE REPORT DID NOT IDENTIFY A FACILITY OR PROVIDE ANY FACILITY CONTACT INFO. THE REPORT DID INDICATE THAT THE DEVICES WERE AVAILABLE FOR EVAL. CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE BAG SPIKE & 5"SPIKE ADAPTOR W/SPIROS ACCESSORY DEVICES FPA ICU MEDICAL, INC. 20116-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI HOSPIRA 11948-02 LIFESHIELD PLUM SET