BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA 11 GAUGE

    MDR report key: 3880831 · Received May 29, 2014

    Report

    Report Number
    9616066-2014-00493
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 3, 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). THE CONCOMITANT PRODUCT HAS BEEN RECEIVED (THE SUSPECT DISPOSABLE WAS NOT RECEIVED) AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV SET MALE LUER DISCONNECTED FROM THE LUER LOCKING CANNULA FEMALE LUER DURING TPN INFUSION. THE CUSTOMER REPORTED, "AT BEDSIDE I SMELLED TPN AND LOOKED AROUND AND DID NOT SEE A LEAK ANYWHERE AFTER ABOUT AN HOUR I LOOKED AGAIN AND CONTINUED TO SMELL IT THEN I LOOKED ON THE BED AND THERE WAS A WET SPOT AND SOME ON THE FLOOR. I IMMEDIATELY TURNED OFF THE TPN AND PUT ON A NEW." 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
    317152 LOCKING BLUNT CANNULA 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORPORATION 9391-0300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS ADMINISTRATION SET: 2122-0007, LOT UNK