BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BLUNT CANNULA, 11 GAUGE

    MDR report key: 4161082 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00698
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 18, 2014
    Report Date
    January 16, 2025
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 LUER LOCKING CANNULA FEMALE LUER DISCONNECTED FROM EXTENSION SET MALE LUER AND LEAKED MEDICATION ONTO FLOOR DURING INFUSION. 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
    430729 LOCKING BLUNT CANNULA, 11 GAUGE ACCESS DEVICE FPA CAREFUSION CORPORATION 9391-0300 1370283901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ALARIS PC UNIT: SN UNK| LOT UNK| PUMP MODULE: SN UNK| VERSASAFE SPLIT SEPTUM SET: MODEL 10796814, | PUMP MODULE: SN UNK| ALARIS PC UNIT: SN UNK| LOT UNK| VERSASAFE SPLIT SEPTUM SET: MODEL 10796814,