BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA 11 GAUGE

    MDR report key: 3872528 · Received May 21, 2014

    Report

    Report Number
    9616066-2014-00486
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CAREFUSION CORP
    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). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVAL IS PENDING. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE IV SET MALE LUER DISCONNECTED FROM THE LUER LOCKING CANNULA FEMALE LUER DURING HEPARIN INFUSION. THERE WAS BLOOD NOTICED IN THE PT'S BED AND UPON INVESTIGATION IT WAS NOTED THAT THE LUER LOCKING CANNULA WAS STILL CONNECTED TO SPLIT SEPTUM CONNECTOR. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303390 LOCKING BLUNT CANNULA 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORP 9391-0300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 2123-0007/LOT UNK,| ALARIS ADMIN SET, 2123-0007/LOT UNK,