BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA 11 GAUGE

    MDR report key: 3904919 · Received June 4, 2014

    Report

    Report Number
    9616066-2014-00499
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 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). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED DISCONNECTION AND LEAK BECAUSE THE CANNULA HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT 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 DURING HEPARIN INFUSION. THE PATIENT WAS LYING IN BED AND NOTICED BLOOD LEAKING AND CLAMPED THE IV LINE. THERE WAS AN ESTIMATED 50ML BLOOD LOSS. 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
    327989 LOCKING BLUNT CANNULA 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORPORATION 9391-0300 UNK

    Patients

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