BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA 11 GAUGE

    MDR report key: 3872529 · Received May 21, 2014

    Report

    Report Number
    9616066-2014-00483
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K945070
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED DISCONNECTION AND LEAK BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV SET MALE LUER DISCONNECTED FROM THE LUER LOCKING CANNULA FEMALE LUER AND BLOOD WAS LEAKING FROM THE LUER LOCKING CANNULA THAT WAS STILL CONNECTED TO SPLIT SEPTUM CONNECTOR. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303705 LOCKING BLUNT CANNULA 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORPORATION 9391-0300 1370283901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS ADMINISTRATION SET: MODEL/LOT UNK