BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA, 11 GAUGE

    MDR report key: 4161066 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00696
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 30, 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
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SECONDARY ZOSYN INFUSION WAS LEAKING AT THE LUER LOCKING CANNULA FEMALE LUER AND PRIMARY IV SET MALE LUER CONNECTION. THIS WAS NOTICED APPROX 20 MINUTES AFTER THE INFUSION WAS STARTED. 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
    431036 LOCKING BLUNT CANNULA, 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORPORATION 9391-0200 1370263802

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Male ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODEL 2123-0007,| LOT UNK| PUMP MODULE: SN UNK| SECONDARY TUBING: MFR/MODEL/LOT UNK| LOT UNK| ALARIS PC UNIT: SN UNK| SECONDARY TUBING: MFR/MODEL/LOT UNK| PUMP MODULE: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODEL 2123-0007,