BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA, 11 GAUGE

    MDR report key: 4161010 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00693
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K945070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PT WAS UP IN RECLINER AND NOTICED THE LUER LOCKING CANNULA WAS STILL CLIPPED INTO SPLIT SEPTUM CONNECTOR, BUT THE FEMALE LUER WAS DISCONNECTED FROM EXTENSION SET MALE LUER AND BLOOD WAS LEAKING. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431034 LOCKING BLUNT CANNULA, 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORPORATION 9391-0200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Male VERSASAFE SPLIT SEPTUM SET, MODEL # 10796814,| VERSASAFE SPLIT SEPTUM SET, MODEL # 10796814,| LOT # UNK